FDA 510(k) Application Details - K110616

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K110616
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	LISA CHARTER Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2011
Decision Date	06/29/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review