510(k) K172713 · PRI Procalcitonin Assay
Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 10, 2017 |
| Received | Sep 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172713
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.