FDA 510(k) Application Details - K061686

Device Classification Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species   More FDA Info for this Device
510(K) Number	K061686
Device Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Applicant	GENEOHM SCIENCES CANADA, INC. PO BOX 103 BALDWIN, MD 21082 US Other 510(k) Applications for this Company
Contact	Judi Smith Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2006
Decision Date	08/30/2006
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