FDA Product Code JFT: Fluorometric, Cortisol
Leading manufacturers include Roche Diagnostics.
FDA 510(k) Cleared Fluorometric, Cortisol Devices (Product Code JFT)
About Product Code JFT - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code JFT since 1983, with 20 receiving FDA clearance (average review time: 125 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 JFT have taken an average of 329 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
JFT devices are reviewed by the Chemistry panel. Browse all Chemistry devices →