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

    IL TEST(TM) HDL CHOLESTEROL

    K Number: K914811 · Decision Jan 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    321
    Review Days
    76

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    Basic Information

    Device Name
    IL TEST(TM) HDL CHOLESTEROL
    K Number
    K914811
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    October 25, 1991
    Decision Date
    January 9, 1992
    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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