BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Glucose Oxidase, Glucose

    PMA: P990026 · Supplement: S007 · Decision Oct 25, 2001
    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
    S007
    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
    October 25, 2001
    Date Received
    August 28, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.

    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