# Stat Chem, Inc.

- Location (FDA's records): Orange, CA
- FDA decisions: 1 (2004–2004): 1 510(k) clearance
- Product codes: CEM (1)
- Predicates its devices cite: 3 (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
- Portable Diagnostic Services, Inc.: 1 (https://510kreport.com/company/portable-diagnostic-services)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Corning Medical & Scientific: 1 (https://510kreport.com/company/corning-medical-scientific)

## Recent decisions
- K042270: Stat K in Vitro Diagnostic Test System (Oct 6, 2004)

Source page: https://510kreport.com/company/stat-chem