510(k) K081615 ยท DHX System, Test, Carcinoembryonic Antigen
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
| Applicant | Olympus America, Inc., Co. Clare, IE |
| Decision | Substantially Equivalent, Mar 18, 2009 |
| Received | Jun 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081615
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.