510(k) K811394 ยท DHX System, Test, Carcinoembryonic Antigen
CEA DESALTING DOLUMN SEPHADEX R
| Applicant | Immuno-Diagnostic Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 12, 1981 |
| Received | May 18, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811394
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.