510(k) K171975 · JTN Susceptibility Test Discs, Antimicrobial
HardyDisk AST Delafloxacin 5 µg (DLX5)
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Aug 1, 2017 |
| Received | Jun 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171975
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.