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    K Number
    K991498
    Device Name
    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1999-06-16

    (48 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

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

    Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a clearance letter from the FDA for a medical device (Accuwell™ Total Galactose kits) and an "Indications For Use" statement. It does not contain any scientific study data or performance metrics.

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