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

    Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

    K Number: K181599 · Decision Mar 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    8
    Review Days
    273

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    Basic Information

    Device Name
    Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
    K Number
    K181599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter
    Date Received
    June 18, 2018
    Decision Date
    March 18, 2019
    Product Code
    QFS
    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
    QFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

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