BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CELLTRACKS ANALYZER II

    K Number: K060110 · Decision Mar 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    CELLTRACKS ANALYZER II
    K Number
    K060110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6020
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunicon Corp.
    Date Received
    January 17, 2006
    Decision Date
    March 16, 2006
    Product Code
    NQI
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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