510(k) Medical Genetics Devices

FDA 510(k) Cleared Medical Genetics Devices

This page lists all 19 medical devices in the Medical Genetics specialty that have been submitted to the FDA through the 510(k) premarket notification process. Genetic testing systems, molecular diagnostics and genomic analysis tools.

• 11 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 399 days.
• Records available from 2016 to the present.
• Filter by product code using the sidebar to narrow results by device type.