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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c-reactive protein, antigen, antiserum, and control
510(k) Number K121558
Model DZ135B-SMA
Device Name DIAZYME HSCRP POC TEST KIT
Original Applicant
DIAZYME LABORATORIES
12889 gregg court
poway,  CA  92064
Original Contact abhijit datta
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JJX  
Date Received05/29/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
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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