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510(k) Data Aggregation

    K Number
    K120247
    Device Name
    EASYDEX
    Manufacturer
    VINELAND SYRUP INC.
    Date Cleared
    2012-06-21

    (146 days)

    Product Code
    MRV
    Regulation Number
    862.1345
    Why did this record match?
    Product Code :

    MRV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyDeX is a flavored non-carbonated beverage containing specific quantities of dextrose (D-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.
    Device Description
    EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The product is manufactured in two (2) flavors (Fruit Punch and Orange) and three (3) concentrations.
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    K Number
    K042183
    Device Name
    GLUCOSE TOLERANCE BEVERAGE
    Manufacturer
    EVER SCIENTIFIC
    Date Cleared
    2004-10-27

    (77 days)

    Product Code
    MRV
    Regulation Number
    862.1345
    Why did this record match?
    Product Code :

    MRV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glucose Drink is a flavored beverage containing specific amounts of dextrose (D-glucose). Manufactured beverages contain three different amounts of glucose; 50,75, and 100 grams quantities per 10 oz bottle. This product is consumed in the In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and other related illnesses.
    Device Description
    Glucose Drink is a water-based non-carbonated flavored beverage containing specific quantities of dextrose. We are marketing three flavors; orange, fruit punch, and lemonlime. Each flavor will have glucose concentrations of 50, 75, 100 grams of D-glucose per 10 oz bottle.
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    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?
    Product Code :

    MRV

    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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