510(k) K231568 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jul 6, 2023 |
| Received | May 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231568
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.