CardioPhase® hsCRP
FDA 510(k) K232624 · Siemens Healthcare Diagnostic Products GmbH
510(k) numberK232624
Submission
- Device name
- CardioPhase® hsCRP
- Applicant
- Siemens Healthcare Diagnostic Products GmbH
Marburg, DE - Received
- August 29, 2023
- Decision date
- November 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
Other 510(k)s with product code DCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221119 | RCRP Flex reagent cartridgeDCN · Special | Siemens Healthcare Diagnostics, Inc. | 03/17/2023SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | Roche Diagnostics Operations (Rdo) | 02/21/2020SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | The Binding Site Group , Ltd. | 10/12/2018SE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | The Binding Site Group , Ltd. | 02/28/2018SE |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentDCN · Traditional | Meso Scale Diagnostics, LLC | 01/12/2018SE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUSDCN · Traditional | The Binding Site Group | 04/05/2017SE |
| K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)DCN · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/17/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
| K083444 | C-Reactive Protein (Latex)DCN · Traditional | Roche Diagnostics Corp. | 03/18/2009SE |
| K083412 | Pathfast HscrpDCN · Traditional | Mitsubishi Kagaku Iatron | 03/09/2009SE |
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Questions and answers
When was CardioPhase® hsCRP cleared by the FDA?
CardioPhase® hsCRP (K232624) received a 510(k) decision of Substantially Equivalent on November 27, 2023, 90 days after the submission was received.
What is the product code of K232624?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.