Company ยท US
Siemens Medical Solutions Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2011. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 1 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 |
| MKW | Cyclosporine | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 1 |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 2011 | K100910 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 Siemens Medical Solutions Diagnostics | DHB |
| Oct 28, 2009 | K091984 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 Siemens Medical Solutions Diagnostics | DHB |
| Jan 8, 2009 | K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS Siemens Medical Solutions Diagnostics | LCP |
| Sep 11, 2008 | K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR Siemens Medical Solutions Diagnostics | MKW |
| Jun 27, 2008 | K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 Siemens Medical Solutions Diagnostics | MQM |
| Apr 1, 2008 | K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS Siemens Medical Solutions Diagnostics | DCN |
| Nov 5, 2007 | K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP Siemens Medical Solutions Diagnostics | LTK |
| Oct 9, 2007 | K071466 | DCA VANTAGE, MODEL 5075 Siemens Medical Solutions Diagnostics | LCP |
| Oct 5, 2007 | K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS Siemens Medical Solutions Diagnostics | JIX |
| Aug 3, 2007 | K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Medical Solutions Diagnostics | JFY |
| May 2, 2007 | K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) Siemens Medical Solutions Diagnostics | NQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle Kit, Catalog#10386287.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pla Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water Feed Kit, Catalog#10288216,#10389714.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urin Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Direct Water feed Kit, Catalog#10373222 Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Accessory Kit, Catalog#10282965, #10373217,#10286080.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasm Terminated |
JJE | K970227 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle, Catalog#10291587.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine sam Terminated |
JJE | K970277 |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water bottles, Catalog#10380062, #10291586.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pl Terminated |
JJE | K970227 |
| Jun 19, 2014 | Siemens Medical Solutions Diagnostics VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual Terminated |
LXG | K970227 |
| Apr 2, 2014 | Siemens Medical Solutions Diagnostics IMMULITE 2000; IMMULITE 2000XPi; VersaCell
The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine Terminated |
JJE | K970227 |
| May 26, 2009 | Siemens Medical Solutions Diagnostics Immulite 2000 and Immulite 2500 digital Fluidics PC Board,
Part Number 450116-0002.
Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Terminated |
DGC | K033234 K970227 |
| Dec 23, 2008 | Siemens Medical Solutions Diagnostics IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the Terminated |
JLS | K944211 |
| Sep 16, 2008 | Siemens Medical Solutions Diagnostics COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy. Terminated |
LTJ | None listed |
| Sep 1, 2008 | Siemens Medical Solutions Diagnostics In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro d Terminated |
JHI | K032563 |
| Sep 1, 2008 | Siemens Medical Solutions Diagnostics Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system
Product Number: 1760 Terminated |
JHI | None listed |
| Jun 5, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, T Terminated |
MMI | K053020 |
| May 6, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591. Terminated |
LOL | K971418 |
| Mar 1, 2007 | Siemens Medical Solutions Diagnostics Sample Management System software for in vitro diagnostic testing
Product # 030102-03 Terminated |
CDD | None listed |