BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    AMERLITE MAB FT4 ASSAY

    K Number: K955097 · Decision Dec 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    AMERLITE MAB FT4 ASSAY
    K Number
    K955097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kodak Clinical Diagnostics, Ltd.
    Date Received
    November 7, 1995
    Decision Date
    December 20, 1995
    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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