510(k) K850358 ยท JTN Susceptibility Test Discs, Antimicrobial
CEFTRIAXONE 30 MCG SENSI-DISC
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Mar 20, 1985 |
| Received | Jan 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.