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

    T-UPTAKE MICROASSAY

    K Number: K885034 · Decision Feb 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    68
    Review Days
    59

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    Basic Information

    Device Name
    T-UPTAKE MICROASSAY
    K Number
    K885034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diamedix Corp.
    Date Received
    December 5, 1988
    Decision Date
    February 2, 1989
    Product Code
    CEE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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