510(k) Chemistry Devices

FDA 510(k) Cleared Chemistry Devices

This page lists all 13207 medical devices in the Chemistry specialty that have been submitted to the FDA through the 510(k) premarket notification process. In vitro diagnostic reagents, analyzers and clinical chemistry test systems.

• 13176 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 88 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.