FDA 510(k) Applications Submitted by SCOTT A CAMPBELL,PH.D.,MBA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K142045 |
07/28/2014 |
XPERT FLU/RSV XC ASSAY |
CEPHEID |
| K160901 |
04/01/2016 |
Xpert Carba-R |
CEPHEID |
| K161619 |
06/13/2016 |
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 |
Cepheid |
| K162331 |
08/19/2016 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
| K162444 |
08/31/2016 |
Xpert MRSA NxG |
CEPHEID |
| K162456 |
09/02/2016 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
| K152614 |
09/14/2015 |
Xpert Carba-R |
CEPHEID |
|
|
