510(k) K250956 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Gepotidacin 10µg (GEP10)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jun 26, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250956
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.