FDA 510(k) Application Details - K083744

Device Classification Name	Kit, Direct Antigen, Positive Control   More FDA Info for this Device
510(K) Number	K083744
Device Name	Kit, Direct Antigen, Positive Control
Applicant	BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	Anne Jepson Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	MJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2008
Decision Date	09/01/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review