510(k) K201017 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
| Applicant | Geneohm Sciences Canada, Inc. (Bd Life Sciences), Quebec, CA |
| Decision | Substantially Equivalent, Oct 18, 2021 |
| Received | Apr 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201017
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.