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

    FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

    K Number: K971141 · Decision Apr 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    91
    Applicant Total
    13
    Review Days
    31

    Basic Information

    Device Name
    FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
    K Number
    K971141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DADE CHEMISTRY SYSTEMS, INC.
    Date Received
    March 28, 1997
    Decision Date
    April 28, 1997
    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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