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510(k) Data Aggregation

    K Number
    K990424
    Device Name
    ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-03-31

    (48 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Liquid Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Abbott Liquid Immunology Control. The letter indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, the document does not contain the acceptance criteria or the study details for the Abbott Liquid Immunology Control.

    Therefore, I cannot provide the requested information. The text is a regulatory approval letter, not a scientific study report or a summary of performance data.

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