510(k) K981478 ยท DHX System, Test, Carcinoembryonic Antigen
ACS:CENTAUR CEA
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Aug 12, 1998 |
| Received | Apr 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981478
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.