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510(k) Data Aggregation

    K Number
    K032753
    Device Name
    GLUCOSE TOLERANCE BEVERAGE
    Manufacturer
    PERK SCIENTIFIC, INC.
    Date Cleared
    2003-11-18

    (74 days)

    Product Code
    MRV
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERK SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions. The beverage is used as an accessory to an In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and related disease conditions.
    Device Description
    Glucose Tolerance Beverage is a water-based flavored beverage containing specific quantities of dextrose. Glucose Tolerance Beverage is a water-based flavored beverage with specific amounts of dextrose.
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