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510(k) Data Aggregation

    K Number
    K023032
    Device Name
    LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2002-10-08

    (27 days)

    Product Code
    GFS
    Regulation Number
    864.8625
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL

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

    Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a government letter concerning the substantial equivalence determination for a medical device called "Glycosylated Hemoglobin A1C Control Normal and Elevated." It informs the manufacturer that they can market the device.

    However, the document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is solely an administrative notification of regulatory clearance.

    Therefore, I cannot provide the requested table and study details based on the input text.

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