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

    ANALYTE T4-THYROXINE

    K Number: K800385 · Decision Mar 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    157
    Review Days
    26

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    Basic Information

    Device Name
    ANALYTE T4-THYROXINE
    K Number
    K800385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    February 22, 1980
    Decision Date
    March 19, 1980
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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