510(k) Immunology Devices

FDA 510(k) Cleared Immunology Devices

This page lists all 3780 medical devices in the Immunology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Immunoassay systems, allergy tests and immunological diagnostic devices.

• 3767 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 104 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.