FDA 510(k) Application Details - K133851

Device Classification Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies   More FDA Info for this Device
510(K) Number	K133851
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	DANIELLE A BRIGGEMAN 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	12/19/2013
Decision Date	09/03/2014
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