FDA 510(k) Applications for Medical Device Product Code: OUY ()

FDA 510(k) Applications for Medical Device Product Code "OUY"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K130268	BECTON, DICKINSON & CO.	BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY	08/23/2013
K182692	Becton, Dickinson and Company	BD MAX CTGCTV2, BD MAX System	01/08/2019
K151589	BECTON, DICKINSON, AND COMPANY	BD MAX CT/GC/TV, BD MAX INSTRUMENT	09/06/2016
K161619	Cepheid	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems	08/29/2016
K151565	CEPHEID	Xpert« TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit	10/16/2015
DEN110012	GEN-PROBE INCORPORATED	APTIMA TRICHOMONAS VAGINALIS ASSAY	04/19/2011
K122062	GEN-PROBE, INC.	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER	01/09/2013
K231316	Hologic, Inc.	Aptima Trichomonas vaginalis Assay	11/06/2023
K143329	QUIDEL CORPORATION	AmpliVue Trichomonas Assay	03/17/2015
K161182	QUIDEL CORPORATION	Solana Trichomonas Assay	08/15/2016