FDA 510(k) Application Details - K091667

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K091667
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. TORONTO, ONTARIO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	GLORIA LEE Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2009
Decision Date	06/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review