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510(k) Data Aggregation

    K Number
    K034013
    Device Name
    REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2004-01-08

    (15 days)

    Product Code
    LKJ
    Regulation Number
    866.5100
    Type
    Special
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit (REAADS® Anti-dsDNA Quantitative Test Kit). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device for the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

    Therefore, I cannot provide the requested information based on the input document.

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