FDA 510(k) Application Details - K150031

Device Classification Name	Kit, Identification, Enterobacteriaceae   More FDA Info for this Device
510(K) Number	K150031
Device Name	Kit, Identification, Enterobacteriaceae
Applicant	MIACOM DIAGNOSTICS GMBH MEROWINGERPLATZ 1A DUSSELDORF 40225 DE Other 510(k) Applications for this Company
Contact	EVE BLOMEKE 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	01/08/2015
Decision Date	10/01/2015
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