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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hexokinase, glucose
510(k) Number K120369
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
Original Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 clyde ct.
mountain view,  CA  94043
Original Contact bunichiro nakajima
Regulation Number862.1345
Classification Product Code
CFR  
Date Received02/06/2012
Decision Date 05/10/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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