510(k) K191931 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jul 31, 2019 |
| Received | Jul 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191931
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.