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

    DxH 520 Hematology Instrument

    K Number: K181475 · Decision Mar 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    8
    Review Days
    270

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    Basic Information

    Device Name
    DxH 520 Hematology Instrument
    K Number
    K181475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter
    Date Received
    June 4, 2018
    Decision Date
    March 1, 2019
    Product Code
    GKZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GKZ Counter, Differential Cell

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