BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Glucose Oxidase, Glucose

    PMA: P990026 · Supplement: S014 · Decision Aug 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    145
    Registration Numbers
    145

    Basic Information

    Device Name
    Glucose Oxidase, Glucose
    Trade Name
    GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
    PMA Number
    P990026
    Supplement Number
    S014
    Device Class
    FDA Class 2
    Product Code
    CGA
    Generic Name
    GLUCOSE OXIDASE, GLUCOSE
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 23, 2002
    Date Received
    August 8, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE AUTOSENSOR FROM 6 MONTHS TO 18 MONTHS.

    Classifications

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

    Product Code Device Name
    CGA Glucose Oxidase, Glucose