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

    CELLSEARCH EPITHELIAL CELL CONTROL KIT

    K Number: K040898 · Decision Jun 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CELLSEARCH EPITHELIAL CELL CONTROL KIT
    K Number
    K040898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Veridex, LLC
    Date Received
    April 6, 2004
    Decision Date
    June 28, 2004
    Product Code
    NRS
    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
    NRS Control Material, Blood Circulating Epithelial Cancer Cell

    Other Clearances by Veridex, LLC

    K Number Device Name
    K130794 CELLTRACKS ANALYZER II SYSTEM
    K122821 CELLTRACKS AUTOPREP SYSTEM
    K110406 CELLTRACKS AUTOPREP SYSTEM
    K113181 CELLTRACKS ANALYER II
    K103502 CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
    K100684 CELLTRACKS AUTOPREP SYSTEM MODEL:9541
    K073338 CELLSEARCH CIRCULATING TUMOR CELL KIT
    K071729 CELLSEARCH CIRCULATING TUMOR CELL KIT
    K062013 CELLSEARCH CIRCULATING TUMOR CELL KIT
    K052191 MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
    Search all 12 clearances from Veridex, LLC →