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

    T-4 RIA REAGENT SET

    K Number: K770676 · Decision May 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    56
    Review Days
    39

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    Basic Information

    Device Name
    T-4 RIA REAGENT SET
    K Number
    K770676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    April 11, 1977
    Decision Date
    May 20, 1977
    Product Code
    CDX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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