FDA Product Code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Leading manufacturers include Abbott Ireland Diagnostics Division, Abbott Laboratories Diagnostics Division and Truvian Health.
FDA 510(k) Cleared Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Devices (Product Code CJE)
About Product Code CJE - Regulatory Context
510(k) Submission Activity
124 total 510(k) submissions under product code CJE since 1976, with 124 receiving FDA clearance (average review time: 62 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 CJE have taken an average of 247 days to reach a decision - up from 59 days historically. Manufacturers should account for longer review timelines in current project planning.
CJE devices are reviewed by the Chemistry panel. Browse all Chemistry devices →