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

    IntelliSep Test

    K Number: K250912 · Decision Nov 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    237

    Basic Information

    Device Name
    IntelliSep Test
    K Number
    K250912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytovale, Inc.
    Date Received
    March 27, 2025
    Decision Date
    November 19, 2025
    Product Code
    QUT
    Advisory Committee
    Microbiology
    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
    QUT Deformability Cytometry For Sepsis Risk Assessment

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