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    K Number
    K053211
    Device Name
    RDI HSFERRITIN KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2006-03-13

    (117 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RDI HSFERRITIN KIT

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

    For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.

    Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a summary of a premarket notification for the RDI Ferritin Kit, which is an in vitro diagnostic device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document primarily focuses on:

    • Device Name: RDI Ferritin Kit
    • Regulation Information: 21 CFR § 866.5340, Regulation Name: Ferritin Immunological Test System, Regulatory Class: II, Product Code: DBF
    • FDA Determination: Substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
    • Indications for Use: Quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, useful in assessing iron stores and evaluating iron deficiency anemia and hemochromatosis.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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