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

    CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM

    K Number: DEN040001 · Decision Jan 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    19

    Basic Information

    Device Name
    CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
    K Number
    DEN040001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.6020
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    ADVANCED DIAGNOSTIC SYSTEMS
    Date Received
    January 2, 2004
    Decision Date
    January 21, 2004
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQI), ordered by most recent decision date.

    CELLTRACKS ANALYZER II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CELLTRACKS AUTOPREP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CELLTRACKS AUTOPREP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CELLTRACKS ANALYER II

    FDA 510(k)
    FDA Class 2 ·Immunology

    CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

    FDA 510(k)
    FDA Class 2 ·Immunology

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all