FDA Product Code JNL: Immunochemical, Thyroglobulin Autoantibody
Leading manufacturers include Beckman Coulter, Inc. and Siemens Healthcare Diagnostics, Inc..
FDA 510(k) Cleared Immunochemical, Thyroglobulin Autoantibody Devices (Product Code JNL)
About Product Code JNL - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code JNL since 1990, with 22 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 2 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 JNL have taken an average of 172 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.
JNL devices are reviewed by the Immunology panel. Browse all Immunology devices →