510(k) K112586 ยท JTN Susceptibility Test Discs, Antimicrobial
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
| Applicant | Becton, Dickinson and Company (BD), Sparks MD, US |
| Decision | Substantially Equivalent, Oct 18, 2011 |
| Received | Sep 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231 Open, Classified |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.