FDA 510(k) Application Details - K082562

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K082562
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	APPLIED BIOSYSTEMS INC 850 LINCOLN CENTER DRIVE FOSTER CITY, CA 94404-1128 US Other 510(k) Applications for this Company
Contact	JOHN D'ANGELO 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	09/04/2008
Decision Date	09/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review