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

    PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

    K Number: K141771 · Decision Nov 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    129

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    Basic Information

    Device Name
    PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
    K Number
    K141771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanostring Technologies, Inc.
    Date Received
    July 1, 2014
    Decision Date
    November 7, 2014
    Product Code
    NYI
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

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