510(k) K921420 ยท JTN Susceptibility Test Discs, Antimicrobial
AZITHROMYCIN, 15 MCG, SENSI DISC
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Cockeysville MD, US |
| Decision | Substantially Equivalent, May 8, 1992 |
| Received | Mar 24, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in vitro susceptibility testing. Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.