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

    ATAC 4700 HEMATOLOGY CELL COUNTER

    K Number: K832116 · Decision Oct 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    ATAC 4700 HEMATOLOGY CELL COUNTER
    K Number
    K832116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Turpen Laboratory Systems, Inc.
    Date Received
    June 30, 1983
    Decision Date
    October 20, 1983
    Product Code
    GIF
    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
    GIF Diluent, Blood Cell

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