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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 K122766
Device Name THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT,  CA  94538
Applicant Contact KAREN LEE
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT,  CA  94538
Correspondent Contact KAREN LEE
Regulation Number862.3840
Classification Product Code
OUF  
Date Received09/10/2012
Decision Date 08/20/2013
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
Recalls CDRH Recalls
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