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

    REAGENT, RIA TRIIODOTHYRONINE T3 (#200)

    K Number: K760078 · Decision Jul 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    REAGENT, RIA TRIIODOTHYRONINE T3 (#200)
    K Number
    K760078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Oxford Laboratories, Inc.
    Date Received
    June 18, 1976
    Decision Date
    July 20, 1976
    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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