Checkcells, Inc. - FDA 510(k) Cleared Devices

Checkcells, Inc. develops AI-powered diagnostic systems for clinical laboratories. The company specializes in automated cell detection and analysis, with a manufacturing facility in Santa Monica, California.

Checkcells has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus is Hematology devices. The cleared device, Seaman Pro/Seaman, represents the company's entry into FDA-regulated diagnostics. Latest clearance occurred in 2026, confirming active regulatory engagement.

Checkcells applies AI and robotics to streamline laboratory workflows. The platform is designed to augment clinical expertise rather than replace it, emphasizing human-centered diagnostic design. The company reports processing over 1 billion proprietary patient cases and achieving 99.7% accuracy in cell analysis.

Explore the company's cleared device names, product codes, and clearance dates in the 510(k) database.