510(k) DEN240020 ยท SEA Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Visby Medical Women's Sexual Health Test
| Applicant | Visby Medical, Inc., San Jose CA, US |
| Decision | Unknown, Mar 28, 2025 |
| Received | May 13, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240020
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.