510(k) Hematology Devices

FDA 510(k) Cleared Hematology Devices

This page lists all 3286 medical devices in the Hematology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Blood analyzers, cell counters and coagulation diagnostic systems.

• 3279 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 112 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.