510(k) K212648 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
VITROS Immunodiagnostic Products CK-MB Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Pencoed, GB |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Aug 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212648
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.