510(k) K003537 ยท JTN Susceptibility Test Discs, Antimicrobial
HARDYDISK RIFAMPIN, 5MCG
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jan 12, 2001 |
| Received | Nov 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003537
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.