510(k) K251337 · JTN Susceptibility Test Discs, Antimicrobial
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
| Applicant | Thermo Fisher Scientific (Oxoid Ltd.), Basingstoke, GB |
| Decision | Substantially Equivalent, Dec 5, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251337
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.