FDA 510(k) Applications for Medical Device Product Code: GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C)

FDA 510(k) Applications for Medical Device Product Code "GNX"
(Antigens, Cf (Including Cf Control), Influenza Virus A, B, C)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K133411	ALERE SCARBOROUGH, INC D/B/A BINAX, INC.	ALERE BINAXNOW INFLUENZA A & B CARD	12/05/2013
K131619	QUIDEL CORP.	QUICKVUE INFLUENZA A+B	06/28/2013
K131606	QUIDEL CORP.	SOFIA INFLUENZA A+B FIA	07/05/2013
K131599	QUIDEL CORPORATION	QUICK VUE INFLUENZA	07/05/2013
K131804	REMEL, INC.	REMEL XPECT FLU A&B	07/12/2013
K132352	SA SCIENTIFIC LTD.	SAS FLUALERT A & B, SAS INFLUENZA A TEST	08/22/2013
K123182	SEKISUI DIAGNOSTICS, LLC	OSOM INFLUENZA A&B TEST MODEL 190	11/05/2012
K971494	ZYMETX, INC.	VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES	09/10/1997