510(k) K191957 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
BD MAX Vaginal Panel
| Applicant | Geneohm Sciences Canada, Inc. (Bd Diagnostics), Quebec, CA |
| Decision | Substantially Equivalent, Oct 21, 2019 |
| Received | Jul 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191957
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.