510(k) K243345 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Aptima BV Assay; Aptima CV/TV Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 25, 2024 |
| Received | Oct 28, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243345
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.