BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gastric Emptying Breath Test

    PMA: P110015 · Supplement: S002 · Decision Jan 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gastric Emptying Breath Test
    Trade Name
    13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
    PMA Number
    P110015
    Supplement Number
    S002
    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
    January 6, 2017
    Date Received
    July 15, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the qualification of additional service providers and the addition of a new test specification for the lyophilized egg (excipient) used in the production of the drug component of the 13C-Spirulina 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