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

    VIDAS TBI (GFAP, UCH-L1)

    K Number: K240279 · Decision May 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    251
    Review Days
    90

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    Basic Information

    Device Name
    VIDAS TBI (GFAP, UCH-L1)
    K Number
    K240279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5830
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    February 1, 2024
    Decision Date
    May 1, 2024
    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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