510(k) K213626 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
VITROS AFP
| Applicant | Ortho Clinical Diagnostics, Pencoed, GB |
| Decision | Substantially Equivalent, Jun 15, 2022 |
| Received | Nov 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213626
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.