FDA 510(k) Application Details - DEN040012

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	DEN040012
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	Affymetrix, Inc. 3380 CENTRAL EXPRESSWAY SANTA CLARA, CA 95051 US Other 510(k) Applications for this Company
Contact	ROBERT LIPSHUTZ 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	11/03/2004
Decision Date	12/23/2004
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review