# Roche Diagnostics/Boehringer Mannheim GmbH

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 3 (1998–1999): 3 510(k) clearances
- Product codes: CGN (1), JPA (1), CIG (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (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
- Biotrack, Inc.: 3 (https://510kreport.com/company/biotrack)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent (1998), cited by 2
- K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay (1998), cited by 1

## Recent decisions
- K983892: Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P (Apr 13, 1999)
- K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay (Aug 25, 1998)
- K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent (Jun 15, 1998)

Source page: https://510kreport.com/company/roche-diagnostics-boehringer-mannheim