510(k) K200215 ยท DHX System, Test, Carcinoembryonic Antigen
ADVIA Centaur CEA Assay
| Applicant | Siemens Healthcare Disgnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 13, 2020 |
| Received | Jan 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200215
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.