510(k) K083444 ยท DCN System, Test, C-Reactive Protein
C-REACTIVE PROTEIN (LATEX)
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 18, 2009 |
| Received | Nov 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2020 | Roche Diagnostics Operations, Inc. Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzer Terminated |
DCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.