FDA 510(k) Application Details - K081309

Device Classification Name	Kit, Identification, Enterobacteriaceae   More FDA Info for this Device
510(K) Number	K081309
Device Name	Kit, Identification, Enterobacteriaceae
Applicant	ADVANDX, INC. 10A ROESSLER ROAD WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	HENRIK STENDER Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2008
Decision Date	12/19/2008
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