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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K103656
Device Name THERMO SCIENTIFIC MAS R DOA TOTAL
Applicant
Microgenics Corporation
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Applicant Contact LISA CHARTER
Correspondent
Microgenics Corporation
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Correspondent Contact LISA CHARTER
Regulation Number862.3280
Classification Product Code
DIF  
Date Received12/15/2010
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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