FDA 510(k) Application Details - K071591

Device Classification Name	More FDA Info for this Device
510(K) Number	K071591
Device Name	RAMP INFLUENZA A/B ASSAY
Applicant	RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY BURNABY, BRITISH COLUMBIA V5J 5J8 CA Other 510(k) Applications for this Company
Contact	KEN PILGRIM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2007
Decision Date	04/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review