510(k) K910506 ยท JTN Susceptibility Test Discs, Antimicrobial
OFLOXACIN, 5 MCG SENSI-DISC
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Mar 4, 1991 |
| Received | Feb 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.