510(k) K231517 ยท DHX System, Test, Carcinoembryonic Antigen
VITROS Immunodiagnostic Products CEA Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, Aug 23, 2023 |
| Received | May 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231517
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.