Company · US
Siemens Healthcare Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
246510(k) clearances (6 in 12 months)
768recalls (15 in 12 months)
645recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 90 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 43 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 40 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 38 |
| JIX | Calibrator, Multi-Analyte Mixture | 32 |
| JIT | Calibrator, Secondary | 28 |
| GKZ | Counter, Differential Cell | 26 |
| MMI | Immunoassay Method, Troponin Subunit | 25 |
| JGS | Electrode, Ion Specific, Sodium | 23 |
| CGN | Acid, Folic, Radioimmunoassay | 17 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 17 |
| JFY | Enzymatic Method, Creatinine | 17 |
| CHP | Radioimmunoassay, Estradiol | 15 |
| LCP | Assay, Glycosylated Hemoglobin | 15 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 14 |
| MOI | System, Test, Immunological, Antigen, Tumor | 14 |
| MRG | System, Test, Vitamin D | 12 |
| NBC | Test, Natriuretic Peptide | 12 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 11 |
| JZO | System, Test, Thyroid Autoantibody | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K253528 | Atellica IM CA 19-9 II Siemens Healthcare Diagnostics, Inc. | NIG |
| Jul 24, 2026 | K261364 | Atellica CH Acetaminophen 2 (ACTM) Siemens Healthcare Diagnostics, Inc. | LDP |
| Feb 27, 2026 | K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Feb 6, 2026 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) Siemens Healthcare Diagnostics, Inc. | JLW |
| Jan 5, 2026 | K251630 | Atellica IM Total PSA II (tPSAII) Siemens Healthcare Diagnostics, Inc. | LTJ |
| Dec 4, 2025 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) Siemens Healthcare Diagnostics, Inc. | JNL |
| Oct 17, 2025 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II Siemens Healthcare Diagnostics, Inc. | JZO |
| Jun 20, 2025 | K242981 | Atellica IM Thyroglobulin (Tg) Siemens Healthcare Diagnostics, Inc. | MSW |
| Apr 25, 2025 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent car Siemens Healthcare Diagnostics | JLW |
| Dec 4, 2024 | K242685 | Atellica® CH Creatinine_3 (Crea3) Siemens Healthcare Diagnostics, Inc. | CGX |
| Jul 26, 2024 | K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) Siemens Healthcare Diagnostics, Inc. | MRR |
| Jul 25, 2024 | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| Apr 4, 2024 | K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) Siemens Healthcare Diagnostics, Inc. | JLW |
| Jan 18, 2024 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) Siemens Healthcare Diagnostics, Inc. | NQD |
| Sep 24, 2023 | K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) Siemens Healthcare Diagnostics, Inc. | NBC |
| Aug 8, 2023 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) Siemens Healthcare Diagnostics, Inc. | LEH |
| Jul 25, 2023 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) Siemens Healthcare Diagnostics, Inc. | JGS |
| Jul 25, 2023 | K221605 | Emit® II Plus Buprenorphine Assay Siemens Healthcare Diagnostics, Inc. | DJG |
| Jul 13, 2023 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) Siemens Healthcare Diagnostics, Inc. | JLW |
| Jun 12, 2023 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Jun 2, 2023 | K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) Siemens Healthcare Diagnostics, Inc. | PQO |
| Mar 20, 2023 | K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Mar 17, 2023 | K221119 | RCRP Flex reagent cartridge Siemens Healthcare Diagnostics, Inc. | DCN |
| Aug 26, 2022 | K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics, Inc. | PRI |
| Nov 24, 2021 | K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) Siemens Healthcare Diagnostics, Inc. | JFY |
| Aug 20, 2021 | DEN190056 | ADVIA Centaur Enhanced Liver Fibrosis (ELF) Siemens Healthcare Diagnostics, Inc. | QQB |
| Jul 16, 2021 | K193397 | ADVIA Centaur® Digoxin assay Siemens Healthcare Diagnostics, Inc. | KXT |
| Jul 13, 2021 | K200210 | ADVIA Centaur® Total hCG assay Siemens Healthcare Diagnostics, Inc. | DHA |
| Jul 2, 2021 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc. | PDJ |
| May 29, 2020 | K200509 | ADVIA Centaur Vitamin D Total (VitD) Siemens Healthcare Diagnostics, Inc. | MRG |
| Apr 6, 2020 | K200199 | ADVIA Centaur CA 125II Siemens Healthcare Diagnostics, Inc. | LTK |
| Mar 27, 2020 | K192240 | RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc. | CHL |
| Feb 13, 2020 | K193489 | ADVIA Centaur BR Siemens Healthcare Diagnostics, Inc. | MOI |
| Jan 15, 2020 | K193493 | ADVIA Centaur Total IgE (tIgE) Siemens Healthcare Diagnostics, Inc. | DGC |
| Nov 25, 2019 | K192788 | ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc. | JFT |
| Nov 22, 2019 | K192777 | ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc. | MOI |
| Oct 30, 2019 | K192790 | Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics, Inc. | DHA |
| Aug 28, 2019 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG Siemens Healthcare Diagnostics, Inc. | CDZ |
| Jul 30, 2019 | K191454 | Atellica CH Amylase_2 (AMY_2) Siemens Healthcare Diagnostics, Inc. | JFJ |
| Jul 17, 2019 | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Qua Siemens Healthcare Diagnostics, Inc. | QFO |
| May 17, 2019 | K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. | MMI |
| Mar 4, 2019 | K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. | MMI |
| Jul 30, 2018 | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. | LFZ |
| Jul 19, 2018 | K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| Jul 16, 2018 | K181002 | Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics, Inc. | PMT |
| Jul 13, 2018 | K173909 | Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics, Inc. | PDJ |
| Jul 12, 2018 | K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| May 25, 2018 | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Siemens Healthcare Diagnostics, Inc. | NDY |
| Apr 12, 2018 | K172201 | Atellica IM Folate Assay Siemens Healthcare Diagnostics, Inc. | CGN |
| Mar 29, 2018 | K172322 | Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics, Inc. | JHI |
Newest 50 of 246.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C-Reactive Protein (RCRP);
Siemens Material Number (SMN): 11537223; Open, Classified |
DCN | K221119 |
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Beckman Coulter, Emit 2000 Quinidine Assay
REF: OSR4Q229
Contents: R1: 2 x 23 mL;R2 2x13 mL Open, Classified |
LBZ | K011605 |
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay
REF: 4Q019UL
Contents: 1x28 mL, 1x14mL Open, Classified |
LBZ | K922913 |
| Aug 5, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin
REF: 11537225 Open, Classified |
JIR | None listed |
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls
SMN 10445390
Catalog No. 7C219UL Open, Classified |
LFG | K821743 |
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit Disopyramide Assay
Enzyme Immunoassay, Lidocaine
SMN 10445370
Catalog No 6N319UL Open, Classified |
KLR | K801204 |
| Jul 8, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. Open, Classified |
PDJ | K200256 |
| Jun 10, 2026 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay Open, Classified |
MLM | K150168 |
| Apr 29, 2026 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System;
Siemens Material Number (SMN): 10736515; Open, Classified |
CHL | K200107 |
| Apr 28, 2026 | Siemens Healthcare Diagnostics, Inc. Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. Open, Classified |
CGX | K132638 |
| Mar 27, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E);
Siemens Material Number (SMN): 11097536; Open, Classified |
PDJ | K200256 |
| Mar 2, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin (UAlb). Material Number: 11537225 Open, Classified |
JIR | None listed |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. Food Panel 3 Specific Allergen;
Siemens Material Number (SMN): 10385891;
Catalog Number: FP3L4; Open, Classified |
DHB | K021208 |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. 3gAllergy Specific IgE Universal Kit;
Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2);
Siemens Material Number (SMN): 10380875;
Catal Open, Classified |
DHB | K101572 |
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Oak Mix Specific Allergen;
Siemens Material Number (SMN): 10386105;
Catalog Number: L2KUN6; Open, Classified |
DHB | K021206 |
| Oct 27, 2025 | Siemens Healthcare Diagnostics, Inc. Assay: IMMULITE 2000 Intact PTH;
Test Code: iPT;
Siemens Material Number (SMN): (1) 10381441, (2) 10381442;
Catalog Number: (1) L2KPP2, (2) L2KPP6; Open, Classified |
CEW | K013566 |
| Sep 8, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. Open, Classified |
CEK | None listed |
| Aug 5, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Open, Classified |
JGS | K200107 |
| Jul 31, 2025 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Open, Classified |
CHL | K002738 |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Open, Classified |
JCN | K993825 |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Open, Classified |
JCN | K993825 |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Open, Classified |
JCN | K993825 |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i SETpoint Calibrator Open, Classified |
KRZ | K840261 |
| Jun 25, 2025 | Siemens Healthcare Diagnostics, Inc. Product: Atellica CH Diluent - CONS 2 x 1.5L;
Siemens Material Number (SMN): 11099300; Open, Classified |
JJE | K151767 |
| May 27, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Open, Classified |
JIS | K013406 |
| May 27, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Open, Classified |
JIS | None listed |
| Apr 29, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & Open, Classified |
CHL | K200107 |
| Apr 29, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4 Open, Classified |
CHL | K200107 |
| Apr 25, 2025 | Siemens Healthcare Diagnostics Inc Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. Open, Classified |
JHX | K051650 |
| Apr 10, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. Open, Classified |
DCN | K221119 |
| Dec 26, 2024 | Siemens Healthcare Diagnostics, Inc. Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; Open, Classified |
JGJ | K140790 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitati Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | K200107 |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative te Open, Classified |
CHL | K200107 |
| Dec 4, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma.
Siemens Material Number (SMN): 11097635 Open, Classified |
JZG | None listed |
| Dec 4, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CI Analyzer. Catalog Numbers: 10947347. Open, Classified |
JJE | K222116 |
| Nov 20, 2024 | Siemens Healthcare Diagnostics, Inc. Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step.
Siemens Material Number(SMN): 11099326
A Open, Classified |
JJE | K161954 |
| Nov 14, 2024 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) Open, Classified |
MTF | None listed |
| Nov 1, 2024 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Open, Classified |
CHL | K200107 |
| Sep 27, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) Open, Classified |
JZO | K003291 |
| Sep 27, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) Open, Classified |
JZO | K003291 |
| Sep 18, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers. Open, Classified |
JIR | None listed |
| Sep 18, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers Open, Classified |
JIR | None listed |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 10 Open, Classified |
NIG | K031393 |
| Sep 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers
SMN: 1049 Open, Classified |
NIG | K031393 |
Newest 50 of 768.