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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K122291
Model OCRD
Device Name THERMO SCIENTIFIC MAS OMNI-CARDIO
Original Applicant
MICROGENICS CORPORATION
46360 fremont blvd
fremont,  CA  94538 6406
Original Contact karen lee
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/31/2012
Decision Date 08/31/2012
Decision substantially equivalent (SE)
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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