FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol
Leading manufacturers include Medicon Hellas S.A and Truvian Health.
FDA 510(k) Cleared Enzymatic Esterase--oxidase, Cholesterol Devices (Product Code CHH)
About Product Code CHH - Regulatory Context
510(k) Submission Activity
230 total 510(k) submissions under product code CHH since 1976, with 230 receiving FDA clearance (average review time: 87 days).
Submission volume has increased in recent years - 2 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 CHH have taken an average of 315 days to reach a decision - up from 85 days historically. Manufacturers should account for longer review timelines in current project planning.
CHH devices are reviewed by the Chemistry panel. Browse all Chemistry devices →