FDA Product Code CGA: Glucose Oxidase, Glucose
Leading manufacturers include Abbott Point of Care, Inc., Nova Biomedical Corporation and Ysi, Inc..
FDA 510(k) Cleared Glucose Oxidase, Glucose Devices (Product Code CGA)
About Product Code CGA - Regulatory Context
510(k) Submission Activity
401 total 510(k) submissions under product code CGA since 1976, with 401 receiving FDA clearance (average review time: 129 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under CGA have taken an average of 817 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.
CGA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →