510(k) K200236 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
VITROS BRAHMS PCT Reagent Pack and Calibrators
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Feb 25, 2020 |
| Received | Jan 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200236
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.