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

    COULTER CELLPREP

    K Number: K021150 · Decision Jun 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    270
    Review Days
    62

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    Basic Information

    Device Name
    COULTER CELLPREP
    K Number
    K021150
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    April 10, 2002
    Decision Date
    June 11, 2002
    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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