FDA 510(k) Applications for Medical Device Product Code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)

FDA 510(k) Applications for Medical Device Product Code "GQG"
(Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K101514	BECTON DICKINSON & CO.	BD DIRECTIGEN EZ RSV	07/09/2010
K022133	BECTON DICKINSON & CO.	BD DIRECTIGEN EZ RSV KIT	12/10/2002
K133140	BECTON DICKINSON & CO.	BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV	11/15/2013
K132456	Becton, Dickinson and Company	BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV	11/07/2013
K121633	Becton, Dickinson and Company	BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV	09/18/2012
K021687	BINAX, INC.	BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK	09/13/2002
K032166	BINAX, INC.	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065	10/21/2003
K021789	INTEGRATED BIOTECHNOLOGY CORP.	QUICKLAB RSV	11/20/2002
K041445	MERIDIAN BIOSCIENCE, INC.	IMMUNOCARD STAT! RSV MODEL #750630	08/13/2004
K070747	QUIDEL CORP.	QUICK VUE RSV TEST, MODELS 20193, 20199	04/23/2007
K101918	QUIDEL CORP.	QUICKVUE RSV 10	09/24/2010
K130398	QUIDEL CORP.	SOFIA(R) RSV FIA	08/13/2013
K162911	Quidel Corporation	Sofia RSV FIA on Sofia 2 analyzer	02/22/2017
K091235	RESPONSE BIOMEDICAL CORP.	RAMP RSV ASSAY	07/24/2009
K022845	SA SCIENTIFIC, INC.	SAS RSV TEST	01/29/2003
K023779	THERMO BIOSTAR, INC.	RSV OIA	01/14/2003
K964870	VIRAL ANTIGENS, INC.	RSV ANTIGEN CONTROL SLIDES	03/18/1997