FDA 510(k) Application Details - K121905

Device Classification Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies   More FDA Info for this Device
510(K) Number	K121905
Device Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
Applicant	ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Angela Drysdale 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	06/29/2012
Decision Date	07/26/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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