FDA 510(k) Application Details - K122766

Device Classification Name	More FDA Info for this Device
510(K) Number	K122766
Device Name	THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Applicant	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	KAREN LEE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2012
Decision Date	08/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review