510(k) Microbiology Devices

FDA 510(k) Cleared Microbiology Devices

This page lists all 7020 medical devices in the Microbiology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Culture systems, microbial identification and infectious disease test kits.

• 6958 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 102 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.