BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P130017 · Supplement: S005 · Decision Dec 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    COLOGUARD
    PMA Number
    P130017
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    PHP
    Generic Name
    System, colorectal neoplasia, DNA methylation and hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 23, 2015
    Date Received
    December 4, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE THE FOLLOWING: USE OF SOFTWARE SPREADSHEET WORKBOOK FOR AUTOMATED DATA PROCESSING IN PLACE OF MANUAL CALCULATIONS OF ACCEPTANCE CRITERIA FOR QUALITYCONTROL (QC) TEST; REVISION OF THE UPPER SPECIFICATION LIMIT FOR QC BLANK POSITIVITY FOR MARKERSBTACT AND ACT; RELOCATION OF THE QC LABORATORIES FROM THE FIRST FLOOR TO THE SECOND FLOORWITHIN THE SAME FACILITY; AND RELOCATION OF THE LABELING AND DISPENSING ACTIVITIES INTO OTHER ROOMSON THE SAME FLOOR.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection