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

    T2 Biothreat Panel

    K Number: K231336 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    130

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    Basic Information

    Device Name
    T2 Biothreat Panel
    K Number
    K231336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4000
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    T2biosystems, Inc.
    Date Received
    May 8, 2023
    Decision Date
    September 15, 2023
    Product Code
    QVR
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QVR Multiplex Nucleic Acid Detection System For Biothreat Agents

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