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

    SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.

    K Number: K871600 · Decision Jun 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    33
    Review Days
    61

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    Basic Information

    Device Name
    SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
    K Number
    K871600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    April 24, 1987
    Decision Date
    June 24, 1987
    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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