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

    SYSMEX NE-1500, MODIFICATION

    K Number: K914744 · Decision Dec 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    33
    Review Days
    69

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    Basic Information

    Device Name
    SYSMEX NE-1500, MODIFICATION
    K Number
    K914744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    October 22, 1991
    Decision Date
    December 30, 1991
    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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