510(k) DEN240045 ยท SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Teal Wand
| Applicant | Teal Health, Inc., San Francisco CA, US |
| Decision | Unknown, May 9, 2025 |
| Received | Aug 27, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240045
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.