510(k) K262113 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Tebipenem 10µg (TBP10)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Aug 20, 2026 |
| Received | Jun 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262113
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.