FDA 510(k) Applications for Medical Device Product Code "PQA"
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K223653 |
Becton, Dickinson and Company |
BD Vaginal Panel |
03/06/2023 |
K212213 |
Cepheid |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
02/09/2022 |
K221160 |
Cepheid |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
06/07/2022 |
DEN160001 |
GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) |
BD MAX Vaginal Panel, BD MAX Instrument |
10/28/2016 |
K191957 |
GeneOhm Sciences Canada, Inc. (BD Diagnostics) |
BD MAX Vaginal Panel |
10/21/2019 |
K201017 |
GeneOhm Sciences Canada, Inc. (BD Life Sciences) |
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit |
10/18/2021 |
K190452 |
Hologic, Inc. |
Aptima BV Assay |
05/23/2019 |
K190472 |
Hologic, Inc. |
Aptima CV/TV Assay |
05/16/2019 |
|
|