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

    Banyan BTI

    K Number: DEN170045 · Decision Feb 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    170

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    Basic Information

    Device Name
    Banyan BTI
    K Number
    DEN170045
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.5830
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Banyan Biomarkers, Inc.
    Date Received
    August 28, 2017
    Decision Date
    February 14, 2018
    Product Code
    QAT
    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
    QAT Brain Trauma Assessment Test

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