510(k) K855106 ยท JTT Susceptibility Test Powders, Antimicrobial
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Paramus NJ, US |
| Decision | Substantially Equivalent, Mar 6, 1986 |
| Received | Dec 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.