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510(k) Data Aggregation

    K Number
    K031604
    Device Name
    GLYCOMARK
    Manufacturer
    TOMEN AMERICA INC.
    Date Cleared
    2003-09-22

    (123 days)

    Product Code
    NOZ, JIS, JJX
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOMEN AMERICA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
    Device Description
    The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
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