510(k) K182357 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Eravacycline 20µg (ERV20)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Sep 26, 2018 |
| Received | Aug 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182357
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.