FDA 510(k) Applications for Medical Device Product Code: OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification)

FDA 510(k) Applications for Medical Device Product Code "OQW"
(2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K111507	CENTERS FOR DISEASE CONTROL AND PREVENTION	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	08/23/2011
K123905	CENTERS FOR DISEASE CONTROL AND PREVENTION	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	01/14/2013
K130551	CENTERS FOR DISEASE CONTROL AND PREVENTION	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	05/22/2013
K101564	CENTERS FOR DISEASE CONTROL AND PREVENTION	CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL	06/22/2010
K120911	CEPHEID	XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)	05/18/2012
K103766	CEPHEID	XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0	04/21/2011
K100148	FOCUS DIAGNOSTICS, INC.	SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500	05/24/2010
K101855	GEN-PROBE PRODESSE, INC	PROFAST+ ASSAY	07/23/2010
K132237	GEN-PROBE PRODESSE, INC.	PRODESSE PROFAST+ ASSAY	08/26/2013
K111778	U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY	JBAIDS INFLUENZA A SUBTYPING KIT	09/13/2011