Hitachi Chemical Diagnostics, Inc.
Hitachi Chemical Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2021, with 1 FDA device recall on record.
Top product codes for Hitachi Chemical Diagnostics, Inc.
FDA recalls by Hitachi Chemical Diagnostics, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hitachi Chemical Diagnostics, Inc.
- K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle
- K182793 — AP3600 Automated Instrument
- K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
- K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
- K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
- K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
- K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
- K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
- K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
- K112910 — AP 72OS SEMI-AUTOMATED INSTRUMENT
- K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
- K120369 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
- K111753 — HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
- K051677 — OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
- K030590 — CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
Data sourced from openFDA. This site is unofficial and independent of the FDA.