510(k) K970830 ยท JTN Susceptibility Test Discs, Antimicrobial
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970830
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.