Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K193613 Allergen-Specific IgE Assay 12 Allergen BundleDHB2021-10-18 View
510(k) K182793 AP3600 Automated InstrumentDHB2019-03-19 View
510(k) K132462 S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRECDN2013-10-28 View
510(k) K130685 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYJFJ2013-08-09 View
510(k) K120945 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTCKA2013-06-07 View
510(k) K131051 HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)JGQ2013-06-07 View
510(k) K131217 S TEST REAGENT CARTRIDGE TOTAL BILIRUBINCIG2013-06-07 View
510(k) K130870 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)CIC2013-05-02 View
510(k) K130141 S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)CJE2013-03-22 View
510(k) K112910 AP 72OS SEMI-AUTOMATED INSTRUMENTDHB2012-12-20 View
510(k) K113809 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)DCN2012-08-17 View
510(k) K120369 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)CFR2012-05-10 View
510(k) K111753 HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDECHH2011-12-14 View
510(k) K051677 OPTIGEN ALLERGEN SPECIFIC IGE ASSAYDHB2006-01-23 View
510(k) K030590 CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)DHB2003-03-21 View
↑