Panels › Clinical Chemistry › Product code JIT · Class 2
Calibrator, Secondary
Regulation 862.1150
0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
Top companies in JIT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. Open, Classified |
JIT | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. Open, Classified |
JIT | None listed |
| Apr 17, 2024 | Randox Laboratories Ltd. Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay
Catalog Number: MA1567 Open, Classified |
JIT | None listed |
| Jan 11, 2024 | Ortho-Clinical Diagnostics, Inc. QMS Tacrolimus Calibrators, Product code 10015573 Open, Classified |
JIT | K123343 |
| Aug 24, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid Open, Classified |
JIT | None listed |
| Jul 11, 2023 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT Open, Classified |
JIT | None listed |
| Oct 13, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Siemens M Open, Classified |
JIT | K131307 |
| Oct 13, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Sieme Open, Classified |
JIT | K131307 |
| Sep 14, 2020 | Tosoh Bioscience Inc Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG
Part number 020361
The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the Terminated |
JIT | None listed |
| Apr 1, 2020 | Abbott Laboratories ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Terminated |
JIT | None listed |
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Calibrators
Ptoduct Usage:
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide Terminated |
JIT | K060964 |
| May 22, 2019 | Abbott Laboratories "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. Terminated |
JIT | K140654 |
| Apr 9, 2019 | Abbott Laboratories ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of th Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic an Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analyt Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in hu Terminated |
JIT | K063232 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (H Terminated |
JIT | K121842 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human Terminated |
JIT | K070822 |
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Calibrator, FR2993
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JIT | K023763 |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in v Terminated |
JIT | K161954 |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro d Terminated |
JIT | K151767 |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Terminated |
JIT | K151792 |
| Sep 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro di Terminated |
JIT | K151792 |
| Mar 5, 2018 | Tosoh Bioscience Inc Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318
The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay. Terminated |
JIT | K100304 |
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899 Terminated |
JIT | K021535 |
| Apr 11, 2017 | Medica Corporation EasyCAL HbA1c Calibrator; REF 10658
Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. Terminated |
JIT | K120497 |
| Jan 5, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integr Terminated |
JIT | K041799 |
| Jul 25, 2016 | Tosoh Bioscience, Inc. Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package.
The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU re Terminated |
JIT | K153417 |
| May 5, 2016 | Siemens Healthcare Diagnostics, Inc. The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only. Terminated |
JIT | K103836 |
| Apr 19, 2016 | Ortho-Clinical Diagnostics The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions ( Terminated |
JIT | K142595 |
| Nov 2, 2015 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products C Terminated |
JIT | K081543 K941142 |
| Jan 8, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085
Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System. Terminated |
JIT | K053576 |
| Oct 6, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. Terminated |
JIT | K051087 |
| Jun 26, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension LOCI TNI Troponin I Calibrator RC 621.
The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Di Terminated |
JIT | K081683 |
| Jun 16, 2014 | Ortho-Clinical Diagnostics VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VI Terminated |
JIT | K041799 |
| May 29, 2014 | Abbott Laboratories ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Terminated |
JIT | K063232 |
| Mar 12, 2014 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, Terminated |
JIT | K121608 |
| Aug 7, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420)
The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase M Terminated |
JIT | K970336 |
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628.
For in vitro diagnostic use in calibrating Intact PTH assays. Terminated |
JIT | K020217 |
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.
For in vitro diagnostic use in calibrating Intact PTH assays. Terminated |
JIT | K020217 |
| Mar 25, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator
The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System. Terminated |
JIT | K061818 |
| Oct 10, 2012 | Beckman Coulter Inc. Access Folate WHO Calibrators, Part Number: A98033.
The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems Terminated |
JIT | K111952 |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Contro Terminated |
JIT | None listed |
| Mar 20, 2012 | Beckman Coulter Inc. Synchron CX Immuno-Protein Cal, part number: 442840,
other product code: CKA
The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is Terminated |
JIT | K883181 |
| Feb 7, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used t Terminated |
JIT | K042643 |
| Jan 11, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic Terminated |
JIT | K081683 |
| May 20, 2011 | Beckman Coulter Inc. SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558
The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibratio Terminated |
JIT | K965108 |
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