510(k) K260184 · SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Onclarity Self-Collection Kit
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, Apr 2, 2026 |
| Received | Jan 21, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260184
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.