FDA 510(k) Application Details - K080995

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K080995
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	Affymetrix, Inc. 3420 Central Expressway Santa Clara, CA 95051 US Other 510(k) Applications for this Company
Contact	MAUREEN J MENDE 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	04/07/2008
Decision Date	07/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review