FDA 510(k) Application Details - K093116

Device Classification Name	More FDA Info for this Device
510(K) Number	K093116
Device Name	MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
Applicant	RESPONSE BIOMEDICAL CORP. 1781 - 75TH AVENUE W. VANCOUVER, B.C V6P 6P2 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	10/02/2009
Decision Date	10/21/2009
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