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

    ANTISMOOTH MUSCLE ANTIBODY TEST SYS

    K Number: K810983 · Decision May 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    12
    Review Days
    18

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    Basic Information

    Device Name
    ANTISMOOTH MUSCLE ANTIBODY TEST SYS
    K Number
    K810983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5120
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immuno-Products Industries
    Date Received
    April 13, 1981
    Decision Date
    May 1, 1981
    Product Code
    DBE
    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
    DBE Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

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    K821576 ANTINUCLEAR ANTIBODY SCREEN FLOURESC
    K810984 ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
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