510(k) K812658 ยท DHX System, Test, Carcinoembryonic Antigen
CEA CONTROL PLASMA
| Applicant | Pacific Hemostasis, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 29, 1981 |
| Received | Sep 18, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812658
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.