510(k) K080194 ยท DHX System, Test, Carcinoembryonic Antigen
VIDAS CEA (S) ASSAY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 9, 2008 |
| Received | Jan 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080194
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.