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

    IN-VITRO TBG RADIOIMMUNOASSAY TEST

    K Number: K810967 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    27
    Review Days
    15

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    Basic Information

    Device Name
    IN-VITRO TBG RADIOIMMUNOASSAY TEST
    K Number
    K810967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Clinical Assays, Inc.
    Date Received
    April 8, 1981
    Decision Date
    April 23, 1981
    Product Code
    CEE
    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
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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