BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P100025 · Supplement: S005 · Decision Apr 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
    PMA Number
    P100025
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    OZA
    Generic Name
    Test, urea adult and pediatric (breath),
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 2014
    Date Received
    June 28, 2013
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE POCONE INFRARED SPECTROPHOTOMETER FOR PEDIATRIC USE.

    Classifications

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

    Product Code Device Name
    OZA Test, Urea Adult And Pediatric (Breath),