FDA Product Code DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Leading manufacturers include Immunalysis Corporation and Sober Ip, LLC.
FDA 510(k) Cleared Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Devices (Product Code DIC)
About Product Code DIC - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code DIC since 1977, with 33 receiving FDA clearance (average review time: 126 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DIC have taken an average of 199 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.
DIC devices are reviewed by the Toxicology panel. Browse all Toxicology devices →