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FDA 510(k)

C-REACTIVE PROTEIN (CRP)

K-Number: K030899 · 2003-07-02

ApplicantAbbott Laboratories
Decision Date2003-07-02
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN (CRP) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2003-07-02 under 510(k) number K030899. 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 C-REACTIVE PROTEIN (CRP)?

C-REACTIVE PROTEIN (CRP) is a medical device that received FDA 510(k) clearance on 2003-07-02. The listed applicant is Abbott Laboratories. The 510(k) number is K030899.

When did C-REACTIVE PROTEIN (CRP) receive FDA 510(k) clearance?

C-REACTIVE PROTEIN (CRP) received FDA 510(k) clearance on 2003-07-02, under 510(k) number K030899.

Who is the listed applicant for C-REACTIVE PROTEIN (CRP)?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-REACTIVE PROTEIN (CRP)?

The FDA product code for C-REACTIVE PROTEIN (CRP) is DCN.

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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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP 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

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.

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