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.