510(k) K072794 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
IMMULITE 2500 OM-MA, MODEL L5KOP
| Applicant | Siemens Medical Solutions Diagnostics, Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 5, 2007 |
| Received | Oct 1, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072794
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.