# Hitachi Chemical Diagnostics, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 16 (2003–2021): 16 510(k) clearances
- Product codes: DHB (5), JFJ (1), DCN (1), CIC (1), CKA (1), JGQ (1), CDN (1), KHS (1), CFR (1), CHH (1), CJE (1), CIG (1)
- Predicates its devices cite: 24 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 14 (https://510kreport.com/company/roche-diagnostics)
- Alfa Wassermann, Inc.: 2 (https://510kreport.com/company/alfa-wassermann)
- Diagnostic Chemicals, Ltd.: 2 (https://510kreport.com/company/diagnostic-chemicals)
- Pharmacia, Inc.: 2 (https://510kreport.com/company/pharmacia)
- Alfa Wassermann Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Mast Immunosystems: 1 (https://510kreport.com/company/mast-immunosystems)

## Its most-cited devices
- K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82) (2003), cited by 1

## Recent decisions
- K193613: Allergen-Specific IgE Assay 12 Allergen Bundle (Oct 18, 2021)
- K182793: AP3600 Automated Instrument (Mar 19, 2019)
- K140248: S Test Reagent Cartridge Carbon Dioxide (CO2) (Mar 11, 2014)
- K132462: S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre (Oct 28, 2013)
- K130685: Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy (Aug 9, 2013)
- K120945: Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast (Jun 7, 2013)
- K131051: Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb) (Jun 7, 2013)
- K131217: S Test Reagent Cartridge Total Bilirubin (Jun 7, 2013)

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