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

    IMMUNICON CELLTRACKS AUTOPREP SYSTEM

    K Number: K040077 · Decision Mar 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    IMMUNICON CELLTRACKS AUTOPREP SYSTEM
    K Number
    K040077
    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
    January 14, 2004
    Decision Date
    March 12, 2004
    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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    Other Clearances by Immunicon Corp.

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