510(k) K192815 ยท PRI Procalcitonin Assay
Elecsys BRAHMS PCT
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 9, 2020 |
| Received | Oct 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192815
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.