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510(k) Data Aggregation

    K Number
    K984225
    Device Name
    LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-12-14

    (19 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K984225
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Liquichek Serum Volatiles 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 Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device called "Liquichek Serum Volatiles Control," focusing on its intended use, description, and comparison to a predicate device for substantial equivalence determination by the FDA. It does not include specific performance metrics, test methodologies, or study results typically associated with device performance validation.

    Therefore, I cannot provide the requested information in the specified format.

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