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

    T3(125) RADIOIMMUNOASSAY KIT

    K Number: K801843 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    T3(125) RADIOIMMUNOASSAY KIT
    K Number
    K801843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technia Diagnostics , Ltd.
    Date Received
    August 1, 1980
    Decision Date
    September 16, 1980
    Product Code
    CDP
    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
    CDP Radioimmunoassay, Total Triiodothyronine

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