FDA 510(k) Application Details - K111778

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	K111778
Device Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant	U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MD 21702 US Other 510(k) Applications for this Company
Contact	PATRICIA M BEVERLY 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	06/23/2011
Decision Date	09/13/2011
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