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 |
| K243725 | Becton, Dickinson and Company | BD Vaginal Panel | 12/19/2024 |
| 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 |
| K231381 | Cepheid | Xpert Xpress MVP; GeneXpert Xpress System | 10/19/2023 |
| 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 |
| K243345 | Hologic, Inc. | Aptima BV Assay; Aptima CV/TV Assay | 11/25/2024 |
| K190472 | Hologic, Inc. | Aptima CV/TV Assay | 05/16/2019 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
