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

    LYPOPROTEIN CHOLESTEROL TEST KIT

    K Number: K780173 · Decision May 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    15
    Review Days
    90

    Basic Information

    Device Name
    LYPOPROTEIN CHOLESTEROL TEST KIT
    K Number
    K780173
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ENVIRONMENTAL CHEMICAL SPECIALTIES
    Date Received
    February 2, 1978
    Decision Date
    May 3, 1978
    Product Code
    JHM
    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
    JHM Colorimetric Method, Lipoproteins

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