510(k) K201312 ยท NBC Test, Natriuretic Peptide
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 4, 2021 |
| Received | May 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201312
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.