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

    MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

    K Number: K905777 · Decision Jan 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    37
    Review Days
    34

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    Basic Information

    Device Name
    MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
    K Number
    K905777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immunotech Corp.
    Date Received
    December 27, 1990
    Decision Date
    January 30, 1991
    Product Code
    CEE
    Advisory Committee
    Clinical Chemistry
    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
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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