510(k) K221197 ยท CEW Radioimmunoassay, Parathyroid Hormone
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, Sep 5, 2023 |
| Received | Apr 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221197
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.