510(k) K171605 ยท MOI System, Test, Immunological, Antigen, Tumor
Elecsys CA 15-3 II
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 20, 2018 |
| Received | Jun 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171605
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.