FDA Product Code DHB: System, Test, Radioallergosorbent (rast) Immunological
Leading manufacturers include Hycor Biomedical and Phadia AB.
FDA 510(k) Cleared System, Test, Radioallergosorbent (rast) Immunological Devices (Product Code DHB)
About Product Code DHB - Regulatory Context
510(k) Submission Activity
264 total 510(k) submissions under product code DHB since 1977, with 264 receiving FDA clearance (average review time: 109 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DHB have taken an average of 171 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
DHB devices are reviewed by the Immunology panel. Browse all Immunology devices →