FDA 510(k) Application Details - K090301

Device Classification Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies   More FDA Info for this Device
510(K) Number	K090301
Device Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
Applicant	BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	SUZANNE VOGEL Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	MYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2009
Decision Date	04/14/2010
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