510(k) K920131 ยท JTN Susceptibility Test Discs, Antimicrobial
CLARITHROMYCIN 15MCG SENSI DISC
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 6, 1992 |
| Received | Jan 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920131
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.