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 |
K143329 |
QUIDEL CORPORATION |
AmpliVue Trichomonas Assay |
03/17/2015 |
K161182 |
QUIDEL CORPORATION |
Solana Trichomonas Assay |
08/15/2016 |
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