FDA 510(k) Application Details - K090964

Device Classification Name	Kit, Screening, Staphylococcus Aureus   More FDA Info for this Device
510(K) Number	K090964
Device Name	Kit, Screening, Staphylococcus Aureus
Applicant	BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	SUZANNE M VOGEL Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2009
Decision Date	12/16/2009
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