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

    CELLTRACKS AUTOPREP SYSTEM MODEL:9541

    K Number: K100684 · Decision Aug 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    12
    Review Days
    169

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    Basic Information

    Device Name
    CELLTRACKS AUTOPREP SYSTEM MODEL:9541
    K Number
    K100684
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Veridex, LLC
    Date Received
    March 10, 2010
    Decision Date
    August 26, 2010
    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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