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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fibrin split products
510(k) Number K112120
Model DZ179A,DZ179A-CAL,DZ179A-CON
Device Name DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
Original Applicant
DIAZYME LABORATORIES
12889 gregg court
poway,  CA  92064
Original Contact abhijit datta
Regulation Number864.7320
Classification Product Code
GHH  
Subsequent Product Codes
DAP   JIT  
Date Received07/25/2011
Decision Date 01/24/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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