510(k) K251501 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Visby Medical Men's Sexual Health Test
| Applicant | Visby Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Oct 1, 2025 |
| Received | May 15, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K251501
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.