FDA 510(k) Application Details - K142738

Device Classification Name	More FDA Info for this Device
510(K) Number	K142738
Device Name	artus HSV-1/2 QS-RGQ MDx Kit
Applicant	QIAGEN 19300 GERMANTOWN ROAD GERMANTOWN, MD 20874 US Other 510(k) Applications for this Company
Contact	Lindsey Howard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2014
Decision Date	12/19/2014
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