510(k) K253105 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Cefiderocol 30µg (FDC30)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | Sep 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Hardy Diagnostics HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435
HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the suscepti Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.