FDA 510(k) immunology devices include diagnostic systems that detect immune responses, antibodies and antigens. The FDA review panel code is IM.
Key categories:
Most devices are Class II under 21 CFR Part 866. Data sourced from FDA 510(k) public files. Updated monthly.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 232d |
| All-time average (cleared) | 104d |
| Not Substantially Equivalent (denied) | 158d |
Recent Immunology submissions have taken longer than the historical average - 232 days in the last 2 years vs 104 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 158 days before receiving a Not Substantially Equivalent determination.
This page lists all 3792 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.
This page lists 3792 medical devices in the Immunology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 3779 were cleared as substantially equivalent to a predicate device. Average FDA review time: 104 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
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