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

    SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER

    K Number: K911626 · Decision Sep 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    1
    Review Days
    155

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    Basic Information

    Device Name
    SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
    K Number
    K911626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Serono Baker Diagnostics System
    Date Received
    April 11, 1991
    Decision Date
    September 13, 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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