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

    ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.

    K Number: K884168 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    13
    Review Days
    56

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    Basic Information

    Device Name
    ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
    K Number
    K884168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The DU Pont Co.
    Date Received
    October 4, 1988
    Decision Date
    November 29, 1988
    Product Code
    JIS
    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
    JIS Calibrator, Primary

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