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:
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.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 191d |
| All-time average (cleared) | 88d |
| Not Substantially Equivalent (denied) | 238d |
Recent Chemistry submissions have taken longer than the historical average - 191 days in the last 2 years vs 88 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 238 days before receiving a Not Substantially Equivalent determination.
This page lists all 13237 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.
This page lists 13237 medical devices in the Chemistry specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 13205 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:
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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