# Bayer Healthcare, Diagnostics Division

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 3 (2004–2005): 2 510(k) clearances and 1 original PMA approval
- Product codes: JIT (1), CGA (1), LOL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K042015: Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase (2004), cited by 1

## Recent decisions
- P040017: Advia Centaur Hav Total Assay, Advia Centaur Hav Total Quality Control Materials (Mar 7, 2005)
- K042015: Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase (Sep 29, 2004)
- K033643: CO2 Calibrator/Diluent (Jan 8, 2004)

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