FDA 510(k) Application Details - K082612

Device Classification Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis   More FDA Info for this Device
510(K) Number	K082612
Device Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Applicant	ADVANDX, INC. 10A ROESSLER ROAD WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	PAULA E BULGER Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	OAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2008
Decision Date	05/05/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review