FDA 510(k) Chemistry Devices
About Chemistry Devices
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Chemistry Devices
This page lists all 13221 medical devices in the Chemistry specialty that have been submitted to the FDA through the 510(k) premarket notification process. In vitro diagnostic reagents, analyzers and clinical chemistry test systems.
- 13190 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 88 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 13221 medical devices in the Chemistry specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 13190 were cleared as substantially equivalent to a predicate device. Average FDA review time: 88 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 chemistry
- 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 chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices