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510(k) Data Aggregation

    K Number
    K021609
    Device Name
    RDI HS CRP KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2002-06-27

    (42 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RDI HS CRP KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For in vitro diagnostic use only. The RDI hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.

    Device Description

    Not Found

    AI/ML Overview

    This letter from the FDA is a clearance letter for a medical device called the "RDI hs CRP Kit (C-reactive protein)". It states the device is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the 510(k) submission document itself, which is not provided here.

    Therefore, I cannot fulfill your request for the table and study details based on the provided text. The document only confirms the FDA's decision to clear the device for marketing.

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