BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AXIS %CDT TURBIDIMETRIC IMMUNOASSAY

    K Number: K992502 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    148

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    Basic Information

    Device Name
    AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
    K Number
    K992502
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1360
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis
    Date Received
    July 26, 1999
    Decision Date
    December 21, 1999
    Product Code
    NAO
    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
    NAO Test, Carbohydrate Deficient Transferrin

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