510(k) K810564 ยท JTN Susceptibility Test Discs, Antimicrobial
CEFOTAXIME 30 MCG. SENSI-DISC.
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Mar 31, 1981 |
| Received | Mar 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607;
5 ug, Catalog No. 291308 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.