FDA 510(k) Application Details - K133936

Device Classification Name	More FDA Info for this Device
510(K) Number	K133936
Device Name	ARTUS C. DIFFICILE QS-RGQ MDX KIT
Applicant	QIAGEN, GMBH 1201 CLOPPER RD GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	Kimberly Mapp Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2013
Decision Date	04/04/2014
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