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

    IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT

    K Number: K800228 · Decision Feb 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    30
    Review Days
    16

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    Basic Information

    Device Name
    IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
    K Number
    K800228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5120
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    February 5, 1980
    Decision Date
    February 21, 1980
    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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