# Genchem, Inc.

- Location (FDA's records): Brea, CA
- FDA decisions: 8 (2004–2009): 8 510(k) clearances
- Product codes: JGS (2), JIX (1), CDS (1), CGA (1), CGX (1), JFL (1), CJY (1)
- Predicates its devices cite: 7 (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
- Beckman Instruments, Inc.: 4 (https://510kreport.com/company/beckman-instruments)
- Hichem Diagnostics: 1 (https://510kreport.com/company/hichem-diagnostics)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Hi Chem, Inc.: 1 (https://510kreport.com/company/hi-chem)

## Recent decisions
- K090283: Calibrator 1,2, and 3 Models: Gen-CAL1, Gen-CAL2, and Gen-CAL3 (Jun 5, 2009)
- K040977: Genchem Electrolyte Buffer (Dec 27, 2004)
- K040973: Bun Reagent (Dec 27, 2004)
- K040974: Glucose Oxidase, Glucose (Dec 27, 2004)
- K040976: Genchem Creatinine Reagent (Dec 27, 2004)
- K040975: Genchem CO2 Acid Reagent (Dec 27, 2004)
- K040972: Calcium, Azo Dye Reagent (Dec 27, 2004)
- K040971: Genchem Ise Electrolyte Reference (Dec 22, 2004)

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