510(k) K023597 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
| Applicant | Beckman Coulter, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 11, 2002 |
| Received | Oct 28, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023597
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.