510(k) K080019 ยท JTN Susceptibility Test Discs, Antimicrobial
HARDYDISK AST DORIPENEM 10 UG
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jan 29, 2008 |
| Received | Jan 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080019
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.