510(k) K220176 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Elecsys AFP
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 15, 2022 |
| Received | Jan 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220176
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.