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

    KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

    K Number: K792610 · Decision Feb 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    92
    Review Days
    66

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    Basic Information

    Device Name
    KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
    K Number
    K792610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    December 18, 1979
    Decision Date
    February 22, 1980
    Product Code
    DBL
    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
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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