# Roche

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 3 (2011–2013): 2 510(k) clearances and 1 original PMA approval
- Product codes: LCP (1), LPS (1), OWD (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diazyme Laboratories: 2 (https://510kreport.com/company/diazyme-laboratories)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- General Atomics: 1 (https://510kreport.com/company/general-atomics)

## Recent decisions
- P120019: Cobas Egfr Mutation Test (May 14, 2013)
- K113793: Homocysteine Test (Jun 5, 2012)
- K102914: TQ HBA1C GEN3 (Jan 20, 2011)

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