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

    IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

    K Number: K152061 · Decision Mar 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    90
    Applicant Total
    32
    Review Days
    223

    Basic Information

    Device Name
    IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
    K Number
    K152061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Received
    July 24, 2015
    Decision Date
    March 3, 2016
    Product Code
    JZO
    Advisory Committee
    Immunology
    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
    JZO System, Test, Thyroid Autoantibody

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