BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LIPPOPROTEIN ELECTROPHORESIS REAGENT SET

    K Number: K771812 · Decision Oct 18, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    42
    Applicant Total
    11
    Review Days
    21

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    Basic Information

    Device Name
    LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
    K Number
    K771812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Gelman Instrument Co.
    Date Received
    September 27, 1977
    Decision Date
    October 18, 1977
    Product Code
    DFC
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

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