510(k) K214122 ยท PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, Jul 28, 2022 |
| Received | Dec 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214122
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.