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FDA 510(k)

CardioPhase® hsCRP

K-Number: K232624 · 2023-11-27

ApplicantSiemens Healthcare Diagnostic Products GmbH
Decision Date2023-11-27
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Siemens Healthcare Diagnostic Products GmbH as applicant

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Related Devices (Code: DCN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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