510(k) DEN160001 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
BD MAX Vaginal Panel, BD MAX Instrument
| Applicant | Geneohm Sciences Canada, Inc. (Bd Diagnostics), Quebec, CA |
| Decision | Unknown, Oct 28, 2016 |
| Received | Jan 11, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160001
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.