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

    ABBOTT CELL-DYN 3500R SYSTEM

    K Number: K960427 · Decision May 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    1
    Review Days
    94

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    Basic Information

    Device Name
    ABBOTT CELL-DYN 3500R SYSTEM
    K Number
    K960427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sequoia Turner Corp.
    Date Received
    January 29, 1996
    Decision Date
    May 2, 1996
    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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