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

    IMMUNOELECTROFILM KIH

    K Number: K770719 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    92
    Review Days
    8

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    Basic Information

    Device Name
    IMMUNOELECTROFILM KIH
    K Number
    K770719
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4500
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    April 18, 1977
    Decision Date
    April 26, 1977
    Product Code
    JZS
    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
    JZS Electrophoresis Instrumentation

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