510(k) K080561 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
VIDAS CA 125 II ASSAY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 10, 2009 |
| Received | Feb 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080561
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.