510(k) K220407 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Visby Medical Sexual Health Test
| Applicant | Visby Medical, San Jose CA, US |
| Decision | Substantially Equivalent, Mar 7, 2023 |
| Received | Feb 14, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K220407
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.