# Rochdiag

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 3 (2001–2007): 3 510(k) clearances
- Product codes: JIX (1), DEM (1), CIG (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Firms that cite its devices most
- Elitechgroup: 3 (https://510kreport.com/company/elitechgroup)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K063744: Cobas Integra C 111 (2007), cited by 4
- K011658: Calibrator for Automated Systems (C.F.a.S.) Lipids (2001), cited by 1

## Recent decisions
- K063744: Cobas Integra C 111 (Jan 17, 2007)
- K011658: Calibrator for Automated Systems (C.F.a.S.) Lipids (Jul 31, 2001)
- K010978: Tina-Quant Alpha-1 Antitrypsin (May 18, 2001)

Source page: https://510kreport.com/company/rochdiag