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

    T3 UPTAKE TEST SYSTEM

    K Number: K802468 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    39
    Review Days
    22

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    Basic Information

    Device Name
    T3 UPTAKE TEST SYSTEM
    K Number
    K802468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    October 9, 1980
    Decision Date
    October 31, 1980
    Product Code
    KHQ
    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
    KHQ Radioassay, Triiodothyronine Uptake

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