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Hitachi Chemical Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0793-2013Class IIIOPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical December 21, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K193613Allergen-Specific IgE Assay 12 Allergen BundleOctober 18, 2021
K182793AP3600 Automated InstrumentMarch 19, 2019
K140248S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)March 11, 2014
K132462S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREOctober 28, 2013
K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYAugust 9, 2013
K131217S TEST REAGENT CARTRIDGE TOTAL BILIRUBINJune 7, 2013
K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARJune 7, 2013
K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)June 7, 2013
K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)May 2, 2013
K130141S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)March 22, 2013
K112910AP 72OS SEMI-AUTOMATED INSTRUMENTDecember 20, 2012
K113809HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)August 17, 2012
K120369HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)May 10, 2012
K111753HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDEDecember 14, 2011
K051677OPTIGEN ALLERGEN SPECIFIC IGE ASSAYJanuary 23, 2006
K030590CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)March 21, 2003