510(k) K201256 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
| Applicant | Procise Diagnostics, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 4, 2022 |
| Received | May 11, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201256
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.