BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gastric Emptying Breath Test

    PMA: P110015 · Supplement: S005 · Decision Aug 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gastric Emptying Breath Test
    Trade Name
    13C-Spirulina Gastric Emptying Breath Test (GEBT)
    PMA Number
    P110015
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    PGE
    Generic Name
    Gastric Emptying Breath Test
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 29, 2019
    Date Received
    March 5, 2019
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changing the manufacturing site for the unit dose packaged 13C-Spirulina/egg mix that constitutes the diagnostic drug product in the Gastric Emptying Breath Test (GEBT).

    Classifications

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

    Product Code Device Name
    PGE Gastric Emptying Breath Test