# Hichem Diagnostics

- Location (FDA's records): Brea, CA
- FDA decisions: 41 (1988–1998): 41 510(k) clearances
- Product codes: JJY (7), JIX (4), CGZ (3), JJX (2), CJY (2), CHH (2), JJE (2), JFL (2), JGS (2), CDS (1), JQB (1), CGX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Genchem, Inc.: 1 (https://510kreport.com/company/genchem)

## Its most-cited devices
- K925611: HI Chem Electrolyte Reference Reagent (1993), cited by 1

## Recent decisions
- K981794: Hichem Calcium Reagent Kit (Jul 29, 1998)
- K963383: Hichem Alp/Amp Reagent Kit (Sep 23, 1996)
- K953862: Hichem Isekci Solution Kit 70010 (Sep 6, 1995)
- K953860: Hichem Ise Diluent Kit 70008 (Sep 6, 1995)
- K953863: Hichem Ise Standards Kit 70011 (Sep 6, 1995)
- K953861: Hichem Ise Intdernal Reference Kit 70009 (Sep 6, 1995)
- K951751: Hichem Ast Reagent Kit (Aug 2, 1995)
- K946192: Hichem Y-GT Reagent Kit (May 2, 1995)

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