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

    ENDAB T4 ENZYME IMMUNOASSAY KIT

    K Number: K821141 · Decision May 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    37
    Review Days
    22

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    Basic Information

    Device Name
    ENDAB T4 ENZYME IMMUNOASSAY KIT
    K Number
    K821141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immunotech Corp.
    Date Received
    April 21, 1982
    Decision Date
    May 13, 1982
    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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