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510(k) Data Aggregation

    K Number
    K062026
    Device Name
    VAP-NT CHOLESTEROL TEST
    Manufacturer
    ATHEROTECH, INC.
    Date Cleared
    2007-03-06

    (231 days)

    Product Code
    CHHLBSMRR
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATHEROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VAP-NT cholesterol test is a device intended to measure total cholesterol, and its component lipoprotein fractions from VLDL to HDL, in fasting serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
    Device Description
    Not Found
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