FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control
Leading manufacturers include Zeus Scientific and Inova Diagnostics, Inc..
FDA 510(k) Cleared Extractable Antinuclear Antibody, Antigen And Control Devices (Product Code LLL)
About Product Code LLL - Regulatory Context
510(k) Submission Activity
180 total 510(k) submissions under product code LLL since 1981, with 180 receiving FDA clearance (average review time: 108 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 LLL have taken an average of 225 days to reach a decision - up from 107 days historically. Manufacturers should account for longer review timelines in current project planning.
LLL devices are reviewed by the Immunology panel. Browse all Immunology devices →