510(k) K160729 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 13, 2016 |
| Received | Mar 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2017 | Roche Diagnostics Corporation Elecsys BRAHMS PCT
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin). Terminated |
PMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.