510(k) K080998 ยท JTN Susceptibility Test Discs, Antimicrobial
DORIPENEM 10UG BBL SENSI-DISC
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Apr 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.