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Hitachi Chemical Diagnostics, Inc.

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Allergen-Specific IgE Assay 12 Allergen Bundle (K193613)Hitachi Chemical Diagnostics, Inc.2021-10-18
AP3600 Automated Instrument (K182793)Hitachi Chemical Diagnostics, Inc.2019-03-19
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (K140248)Hitachi Chemical Diagnostics, Inc.2014-03-11
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (K132462)Hitachi Chemical Diagnostics, Inc.2013-10-28
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685)Hitachi Chemical Diagnostics, Inc.2013-08-09
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945)Hitachi Chemical Diagnostics, Inc.2013-06-07
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051)Hitachi Chemical Diagnostics, Inc.2013-06-07
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217)Hitachi Chemical Diagnostics, Inc.2013-06-07
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870)Hitachi Chemical Diagnostics, Inc.2013-05-02
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (K130141)Hitachi Chemical Diagnostics, Inc.2013-03-22
AP 72OS SEMI-AUTOMATED INSTRUMENT (K112910)Hitachi Chemical Diagnostics, Inc.2012-12-20
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369)Hitachi Chemical Diagnostics, Inc.2012-05-10
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE (K111753)Hitachi Chemical Diagnostics, Inc.2011-12-14
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY (K051677)Hitachi Chemical Diagnostics, Inc.2006-01-23
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) (K030590)Hitachi Chemical Diagnostics, Inc.2003-03-21

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Every clearance here is in the API, with alerts when new ones post.