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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Everolimus Immunoassay
510(k) Number K100144
Device Name THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
Applicant
Microgenics Corp.
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Applicant Contact LISA CHARTER
Correspondent
Microgenics Corp.
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Correspondent Contact LISA CHARTER
Regulation Number862.3840
Classification Product Code
OUF  
Subsequent Product Codes
DLJ   LAS  
Date Received01/19/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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