510(k) K250358 ยท PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Feb 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250358
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.