510(k) K192072 ยท DCN System, Test, C-Reactive Protein
Tina-quant C-Reactive Protein IV
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Aug 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192072
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.