510(k) K200199 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ADVIA Centaur CA 125II
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 6, 2020 |
| Received | Jan 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200199
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.