FDA 510(k) Application Details - DEN140004

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140004
Device Name	QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Applicant	DIAGNOSTIC HYBRIDS, INC. 2005 E State St Ste 100 ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	Ronald H Lollar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2014
Decision Date	05/13/2014
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review