FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control

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 510(k) Review Time - LLL Product Code

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 →

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