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

    THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT

    K Number: K930777 · Decision Apr 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    15
    Review Days
    51

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    Basic Information

    Device Name
    THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT
    K Number
    K930777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nichols Institute
    Date Received
    February 16, 1993
    Decision Date
    April 8, 1993
    Product Code
    JNL
    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
    JNL Immunochemical, Thyroglobulin Autoantibody

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