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

    BLOOD CELL SEPARATOR 2997

    K Number: K771258 · Decision Sep 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    9
    Applicant Total
    8
    Review Days
    56

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    Basic Information

    Device Name
    BLOOD CELL SEPARATOR 2997
    K Number
    K771258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9245
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Business Machines
    Date Received
    July 12, 1977
    Decision Date
    September 6, 1977
    Product Code
    GKT
    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
    GKT Separator, Automated, Blood Cell, Diagnostic

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