FDA 510(k) Application Details - K063127

Device Classification Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis   More FDA Info for this Device
510(K) Number	K063127
Device Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Applicant	ADVANDX, INC. 690 CANTON STREET, SUITE 302 WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	Amy Aulwes 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	10/13/2006
Decision Date	12/22/2006
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