FDA Product Code JKR: Radioimmunoassay, Calcitonin
Leading manufacturers include Roche Diagnostics GmbH.
FDA 510(k) Cleared Radioimmunoassay, Calcitonin Devices (Product Code JKR)
About Product Code JKR - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code JKR since 1979, with 20 receiving FDA clearance (average review time: 108 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 JKR have taken an average of 266 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
JKR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →