FDA 510(k) Application Details - K111507

Device Classification Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification   More FDA Info for this Device
510(K) Number	K111507
Device Name	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD. MS-C12 ATLANTA, GA 30333 Other 510(k) Applications for this Company   More Company Info and Competitors
Contact	CAPT HYE-JOO KIM, PHARM.D. Other 510(k) Applications for this Contact
Regulation Number	866.3332   More FDA Info for this Regulation Number
Classification Product Code	OQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2011
Decision Date	08/23/2011
Decision	CS -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review	N