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

    CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)

    K Number: K874875 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    20
    Review Days
    118

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    Basic Information

    Device Name
    CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
    K Number
    K874875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boots-Celltech Diagnostics, Inc.
    Date Received
    November 27, 1987
    Decision Date
    March 24, 1988
    Product Code
    CEC
    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
    CEC Radioimmunoassay, Free Thyroxine

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