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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 K092051
Device Name THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT,  CA  94538
Applicant Contact LISA CHARTER
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT,  CA  94538
Correspondent Contact LISA CHARTER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/07/2009
Decision Date 09/21/2009
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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