# Bayer Diagnostics Corp.

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 32 (2000–2003): 32 510(k) clearances
- Product codes: JIF (2), JJY (2), GKZ (2), JIT (2), LPS (2), MOI (2), JJX (1), KXT (1), GKR (1), KNK (1), JIX (1), LTK (1)
- Predicates its devices cite: 23 (0 its own); citations of its devices by later devices: 19 (0 its own)
- Recalls linked to its devices: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 5 (https://510kreport.com/company/abbott-laboratories)
- Bayer Corp.: 4 (https://510kreport.com/company/bayer)
- Technicon Instruments Corp.: 2 (https://510kreport.com/company/technicon-instruments)
- Ciba Corning Diagnostics Corp.: 2 (https://510kreport.com/company/ciba-corning-diagnostics)
- Bayer Healthcare, LLC: 2 (https://510kreport.com/company/bayer-healthcare)
- Eastman Kodak Company: 2 (https://510kreport.com/company/eastman-kodak)
- Sigma Chemical Co.: 1 (https://510kreport.com/company/sigma-chemical)
- Nichols Institute Diagnostics: 1 (https://510kreport.com/company/nichols-institute-diagnostics)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 6 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Bayer Healthcare, LLC: 4 (https://510kreport.com/company/bayer-healthcare)
- Biokit, S.A.: 2 (https://510kreport.com/company/biokit)
- Denka Seiken Co., Ltd.: 2 (https://510kreport.com/company/denka-seiken)
- R&D Systems, Inc.: 1 (https://510kreport.com/company/r-d-systems)
- Siemens Helathcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-helathcare-diagnostics)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Tosoh Bioscience, Inc.: 1 (https://510kreport.com/company/tosoh-bioscience)

## Its most-cited devices
- K020217: Acs:180 and Advia Centaur Ipth Immunoassay (2002), cited by 3
- K010050: Advia Centaur and Acs: 180 Folate Immunoassay (2001), cited by 3
- K030452: Bayer Ligand Plus 1, 2, 3 Controls (2003), cited by 2
- K021535: Advia Cantaur and Acs:180 Insulin Calibrator (2002), cited by 2
- K023840: Acid Phosphatase Assay for the Advia 1650 (2003), cited by 2
- K012357: CA 15-3 Assay for the Advia Centaur System (2002), cited by 2

## Recent decisions
- K033379: Bayer Special Chemistry Controls (Dec 19, 2003)
- K033380: Bayer Special Chemistry Calibrators (Dec 16, 2003)
- K033007: Bayer Advia Digoxin Assay for the Integrated Module System (Nov 14, 2003)
- K031857: Advia Chemistry Alpha-1 Antitrypsin Assay (Sep 4, 2003)
- K022096: Uric Acid Assay for the Advia Integrated Modular System (Mar 18, 2003)
- K030452: Bayer Ligand Plus 1, 2, 3 Controls (Mar 3, 2003)
- K023840: Acid Phosphatase Assay for the Advia 1650 (Jan 7, 2003)
- K023841: Ammonia Assay for the Advia 1650 (Dec 24, 2002)

Source page: https://510kreport.com/company/bayer-diagnostics