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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nadh oxidation/nad reduction, alt/sgpt
510(k) Number K120945
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
Original Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 clyde ct.
mountain view,  CA  94043
Original Contact charles tsou
Regulation Number862.1030
Classification Product Code
CKA  
Subsequent Product Code
CIT  
Date Received03/29/2012
Decision Date 06/07/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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