510(k) Toxicology Devices

FDA 510(k) Cleared Toxicology Devices

This page lists all 3024 medical devices in the Toxicology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Drug screening assays, therapeutic drug monitoring and toxicology test panels.

• 3014 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 87 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.