FDA 510(k) Application Details - K121399

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K121399
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	LUMINEX CORP. 12212 Technology Blvd AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	Oliver Meek 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	05/09/2012
Decision Date	01/09/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review