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510(k) Data Aggregation

    K Number
    K992550
    Device Name
    LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-08-11

    (12 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

    Liquichek 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 package insert.

    Device Description

    Liquichek Immunology Control is prepared from human serum with added serum proteins and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

    AI/ML Overview

    The provided document is a 510(k) summary for the Bio-Rad Liquichek Immunology Control. It describes the device, its intended use, and claims substantial equivalence to an existing device. However, it does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics such as sensitivity, specificity, or accuracy that would be derived from a performance study.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on regulatory submission and demonstrating equivalence based on technological characteristics rather than providing performance study results.

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