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

    Glucose Oxidase, Glucose

    PMA: P990026 · Supplement: S017 · Decision Jun 17, 2003
    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
    S017
    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
    June 17, 2003
    Date Received
    June 2, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO AN EQUIVALENT IN-HOUSE SUPPLIER OF THE RAW MATERIAL PLATINUM/CARBON (PT/C) COMPOSITE ELECTRODE INK FOR THE MANUFACTURE OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR.

    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