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

    CELLTRACKS AUTOPREP SYSTEM

    K Number: K122821 · Decision Dec 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    90

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    Basic Information

    Device Name
    CELLTRACKS AUTOPREP SYSTEM
    K Number
    K122821
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.6020
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Veridex, LLC
    Date Received
    September 14, 2012
    Decision Date
    December 13, 2012
    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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    Other Clearances by Veridex, LLC

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