FDA 510(k)

CardioPhase® hsCRP

Número K: K232624 · 2023-11-27

RequerenteSiemens Healthcare Diagnostic Products GmbH

Data da decisão2023-11-27

Código do produtoDCN

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

CardioPhase® hsCRP is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K232624. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CardioPhase® hsCRP?

CardioPhase® hsCRP is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K232624.

When did CardioPhase® hsCRP receive FDA 510(k) clearance?

CardioPhase® hsCRP received FDA 510(k) clearance on 2023-11-27, under 510(k) number K232624.

Who is the listed applicant for CardioPhase® hsCRP?

The FDA 510(k) record lists Siemens Healthcare Diagnostic Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioPhase® hsCRP?

The FDA product code for CardioPhase® hsCRP is DCN.

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Dispositivos Relacionados (Código: DCN)

K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)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 K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

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