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

    ACA THYRONINE UPTAKE (TU E) METHOD

    K Number: K885259 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    13
    Review Days
    56

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    Basic Information

    Device Name
    ACA THYRONINE UPTAKE (TU E) METHOD
    K Number
    K885259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The DU Pont Co.
    Date Received
    December 23, 1988
    Decision Date
    February 17, 1989
    Product Code
    KHQ
    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
    KHQ Radioassay, Triiodothyronine Uptake

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