Bayer Diagnostics Corp.
Medical device manufacturer in Tarrytown, NY.
32510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- GKZ Counter, Differential Cell 2
- LPS Urinary Homocystine (Nonquantitative) Test… 2
- MOI System, Test, Immunological, Antigen, Tumor 2
- JIT Calibrator, Secondary 2
- JIF Enzymatic Method, Ammonia 2
- LDP Colorimetry, Acetaminophen 1
- JIX Calibrator, Multi-Analyte Mixture 1
- LTK Test, Epithelial Ovarian Tumor-Associated… 1
- DIC Alcohol Dehydrogenase, Specific Reagent For… 1
- LOJ Kit, Test,Alpha-Fetoprotein For Testicular… 1
- JPK Mixture, Hematology Quality Control 1
- GKL Counter, Cell, Automated (Particle Counter) 1
- GKR System, Hemoglobin, Automated 1
- DKJ Colorimetry, Salicylate 1
- JZO System, Test, Thyroid Autoantibody 1
- JJX Single (Specified) Analyte Controls… 1
- DKB Calibrators, Drug Mixture 1
- DIH Colorimetry, Cholinesterase 1
- LGD Enzyme Linked Immunoabsorbent Assay… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | 12/19/2003SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | 12/16/2003SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | 11/14/2003SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | 09/04/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | 03/18/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | 03/03/2003SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | 12/24/2002SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
| K022329 | Ca 125 II Assay for the Bayer Advia Integrated Module SystemLTK · Traditional | 11/27/2002SE |
| K023184 | Ethanol Assay for the Bayer Advia Integrated Module SystemDIC · Traditional | 11/18/2002SE |
| K022178 | Ca 15-3 Assay for the Advia Integrated Modular SystemMOI · Traditional | 11/12/2002SE |
| K022668 | Advia 120 Hematology System Complete Blood Count (CBC) MethodGKZ · Traditional | 10/15/2002SE |
| K020807 | Afp Assay for the Advia Integrated Modular SystemLOJ · Traditional | 10/01/2002SE |
| K022968 | Advia Testpoint CSF ControlJPK · Traditional | 09/24/2002SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | 09/11/2002SE |
| K020616 | Bayer Rapidpoint 405 SystemGKR · Traditional | 07/17/2002SE |
| K021151 | Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional | 07/13/2002SE |
| K020794 | Salicylate Assay for the Advia Integrated Modular SystemDKJ · Traditional | 07/11/2002SE |
| K020792 | Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional | 07/11/2002SE |
| K021535 | Advia Cantaur and ACS:180 Insulin CalibratorJIT · Traditional | 06/27/2002SE |
| K021532 | Advia Centaur and ACS:180 C-Peptide CalibratorJIT · Traditional | 06/27/2002SE |
| K020217 | ACS:180 and Advia Centaur Ipth ImmunoassayJJX · Traditional | 03/15/2002SE |
| K012357 | Ca 15-3 Assay for the Advia Centaur SystemMOI · Traditional | 02/28/2002SE |
| K013959 | Bayer Valproic Acid Assay for the ACS:180 and Advia Centaur AnalyzersDKB · Traditional | 01/29/2002SE |
| K013750 | Advia 1650 Cholinesterase AssayDIH · Traditional | 01/18/2002SE |
| K012183 | Bayer Diagnostics Advia Centaur Toxoplasma Igg AssayLGD · Traditional | 12/27/2001SE |
| K013606 | Acs 180 Homocysteine AssayLPS · Traditional | 12/21/2001SE |
| K013406 | Advia Centaur Homocysteine AssayLPS · Traditional | 12/18/2001SE |
| K012904 | Advia 120 Hematology System, Cyanide-Free High DeterminationGKZ · Special | 09/21/2001SE |
| K010050 | Advia Centaur and Acs: 180 Folate ImmunoassayCGN · Traditional | 02/05/2001SE |
| K003291 | Bayer Diagnostics ACS:180 and Advia Centaur Anti-Tpo AssayJZO · Traditional | 12/05/2000SE |