BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM

    K Number: K882767 · Decision Jul 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    33
    Review Days
    12

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    Basic Information

    Device Name
    SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
    K Number
    K882767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    July 6, 1988
    Decision Date
    July 18, 1988
    Product Code
    GKH
    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
    GKH Apparatus, Automated Blood Cell Diluting

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