510(k) K212559 · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
CardioPhase® hsCRP
| Applicant | Siemens Healthcare Diagnostics Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Dec 16, 2022 |
| Received | Aug 13, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212559
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.