FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

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.