FDA 510(k) Application Details - K113319

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K113319
Device Name	Real Time Nucleic Acid Amplification System
Applicant	QIAGEN, GMBH 1201 CLOPPER RD GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	MELISSA MAHALL Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	OOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2011
Decision Date	02/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review