FDA 510(k) Immunology Devices
About Immunology Devices
FDA 510(k) immunology devices include diagnostic systems that detect immune responses, antibodies and antigens. The FDA review panel code is IM.
Key categories:
- Immunoassay analyzers - automated platforms for ELISA, CLIA and lateral flow
- Allergy testing systems - specific IgE measurement and skin prick test devices
- Autoimmune diagnostics - ANA, anti-dsDNA, rheumatoid factor assays
- Transplant diagnostics - HLA typing and crossmatch systems
Most devices are Class II under 21 CFR Part 866. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Immunology Devices
This page lists all 3781 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.
- 3768 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.
How to use this database
This page lists 3781 medical devices in the Immunology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 3768 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:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to immunology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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.
Looking for a specific immunology device? Search by device name, K-number or manufacturer.
Search all Immunology 510(k) devices