510(k) K183298 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Omadacycline 30µg (OMC30)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Nov 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183298
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.