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

    ADVIA Centaur TSH3-Ultra

    K Number: K150403 · Decision May 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    240
    Applicant Total
    32
    Review Days
    72

    Basic Information

    Device Name
    ADVIA Centaur TSH3-Ultra
    K Number
    K150403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Received
    February 18, 2015
    Decision Date
    May 1, 2015
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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