FDA 510(k) Application Details - K053126

Device Classification Name	More FDA Info for this Device
510(K) Number	K053126
Device Name	BINAXNOW INFLUENZA A & B TEST
Applicant	BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	Angela Drysdale 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	11/07/2005
Decision Date	11/30/2005
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