510(k) K213510 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
| Applicant | Siemens Healthcare Diagnostics Products, Ltd., Llanberis, GB |
| Decision | Substantially Equivalent, Sep 8, 2023 |
| Received | Nov 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213510
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.