FDA 510(k) Application Details - K073506

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K073506
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	LUMINEX CORP. 439 UNIVERSITY AVENUE SUITE 2000 TORONTO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	NANCY KRUNIC 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	12/13/2007
Decision Date	03/07/2008
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