FDA 510(k) Application Details - DEN130013

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130013
Device Name	VITEK MS
Applicant	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US Other 510(k) Applications for this Company
Contact	Nancy Weaver Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2013
Decision Date	08/21/2013
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review