FDA 510(k) Application Details - K121991

Device Classification Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis   More FDA Info for this Device
510(K) Number	K121991
Device Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Applicant	ADVANDX, INC. 400 TRADECENTER SUITE 6990 WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	BENJAMIN S CRYSTAL 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	07/06/2012
Decision Date	01/07/2013
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