# Celera Diagnostics

- Location (FDA's records): Alameda, CA
- FDA decisions: 1 (2007–2007): 1 510(k) clearance
- Product codes: NUA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (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
- Tm Bioscience Corporation: 1 (https://510kreport.com/company/tm-bioscience)

## Recent decisions
- K062028: Cystic Fibrosis Genotyping Assay, Model 6L20-01 (Sep 7, 2007)

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