510(k) K250447 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, May 19, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250447
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.