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

    ELIAS TMAB

    K Number: K925923 · Decision Jan 14, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    54
    Review Days
    52

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    Basic Information

    Device Name
    ELIAS TMAB
    K Number
    K925923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    November 23, 1992
    Decision Date
    January 14, 1993
    Product Code
    JZO
    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
    JZO System, Test, Thyroid Autoantibody

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