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

    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

    K Number: K022512 · Decision Sep 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    62

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    Basic Information

    Device Name
    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
    K Number
    K022512
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunicon Corp.
    Date Received
    July 30, 2002
    Decision Date
    September 30, 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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