510(k) K970212 ยท JTN Susceptibility Test Discs, Antimicrobial
LEVOFLOXACIN, 5MCG, SENSI-DISC
| Applicant | Becton Dickinson Microbiology Systems, Cockeysville MD, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.