FDA 510(k) Application Details - K093128

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K093128
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	ILLUMINA, INC. 5200 ILLUMINA WAY SAN DIEGO, CA 92122 US Other 510(k) Applications for this Company
Contact	DONALD R ELLIS 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	10/02/2009
Decision Date	04/28/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review