BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

    K Number: K072523 · Decision Jan 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    137

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    Basic Information

    Device Name
    DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
    K Number
    K072523
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Atomics
    Date Received
    September 7, 2007
    Decision Date
    January 22, 2008
    Product Code
    LBR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LBR Ldl & Vldl Precipitation, Hdl

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