FDA 510(k) Applications Submitted by KERRY J FLOM
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120911 |
03/26/2012 |
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) |
CEPHEID |
| K151226 |
05/07/2015 |
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
CEPHEID |
| K121539 |
05/24/2012 |
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) |
CEPHEID |
| DEN130032 |
06/11/2013 |
XPERT MTB/RIF ASSAY |
CEPHEID |
| K143302 |
11/17/2014 |
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 |
CEPHEID |
| K033982 |
12/23/2003 |
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST |
VYSIS |
| K103766 |
12/23/2010 |
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
CEPHEID |
| K151565 |
06/10/2015 |
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 |
CEPHEID |
| K142501 |
09/05/2014 |
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
|
|
