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

    NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)

    K Number: K874115 · Decision Nov 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    164
    Review Days
    26

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    Basic Information

    Device Name
    NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
    K Number
    K874115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    October 9, 1987
    Decision Date
    November 4, 1987
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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