510(k) K864877 ยท DHX System, Test, Carcinoembryonic Antigen
TRI-LEVEL LIGAND CONTROL
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, May 21, 1987 |
| Received | Dec 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864877
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.