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

    CHOLESTEROL REAGENT

    K Number: K771313 · Decision Aug 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    92
    Review Days
    16

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    Basic Information

    Device Name
    CHOLESTEROL REAGENT
    K Number
    K771313
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 18, 1977
    Decision Date
    August 3, 1977
    Product Code
    CGO
    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
    CGO Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol

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