510(k) K261853 · JTN Susceptibility Test Discs, Antimicrobial
Gepotidacin GEP 10 µg
| Applicant | Liofilchem, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jul 23, 2026 |
| Received | Jun 3, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261853
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.