CardioPhase® hsCRP
K-Number: K232624 · 2023-11-27
Decision Date2023-11-27
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
CardioPhase® hsCRP is a medical device manufactured by Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2023-11-27 under approval number K232624. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CardioPhase® hsCRP?
CardioPhase® hsCRP is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K232624.
When was CardioPhase® hsCRP approved by the FDA?
CardioPhase® hsCRP received FDA 510(k) clearance on 2023-11-27, under approval number K232624.
What company makes CardioPhase® hsCRP?
CardioPhase® hsCRP is manufactured by Siemens Healthcare Diagnostic Products GmbH.
What is the FDA product code for CardioPhase® hsCRP?
The FDA product code for CardioPhase® hsCRP is DCN.
Other Devices by Siemens Healthcare Diagnostic Products GmbH
Related Devices (Code: DCN)
K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group
K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.
K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.
K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC
K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)
K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.