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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
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 (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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