FDA 510(k) Application Details - K110786

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K110786
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	GENMARK DIAGNOSTICS, INC 5964 LA PLACE COURT SUITE 100 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	JOHN RIOLO Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	NSU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2011
Decision Date	12/02/2011
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