FDA 510(k) Application Details - K021646

Device Classification Name	More FDA Info for this Device
510(K) Number	K021646
Device Name	BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Applicant	BINAX, INC. 217 READ ST. PORTLAND, ME 04103 US Other 510(k) Applications for this Company
Contact	Anne Jepson 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	05/20/2002
Decision Date	09/19/2002
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