BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Glucose Oxidase, Glucose

    PMA: P990026 · Supplement: S013 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    145
    Registration Numbers
    145

    Basic Information

    Device Name
    Glucose Oxidase, Glucose
    Trade Name
    GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
    PMA Number
    P990026
    Supplement Number
    S013
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 25, 2002
    Date Received
    June 25, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE GLUCOPAD ASSEMBLY PROCESS IN THE AUTOSENSOR ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS.

    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