Panels › Immunology › Product code DCN · Class 2
System, Test, C-Reactive Protein
Regulation 866.5270
0510(k)s in 12 months (70 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in DCN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C-Reactive Protein (RCRP);
Siemens Material Number (SMN): 11537223; Open, Classified |
DCN | K221119 |
| Apr 10, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. Open, Classified |
DCN | K221119 |
| 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 | K083444 |
| Mar 31, 2020 | The Binding Site Group, Ltd. C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, Terminated |
DCN | K161982 |
| Dec 12, 2019 | The Binding Site Group, Ltd. Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum usin Terminated |
DCN | K172868 |
| Sep 8, 2009 | Siemens Healthcare Diagnostics, Inc. Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP).
In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Mea Terminated |
DCN | K003419 |
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