Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Co-Diagnostics has submitted a 510(k) premarket notification to the FDA for its new upper respiratory point-of-care diagnostic test, aiming to expand rapid testing capabilities in the US healthcare market.

This Wire brief sits within Fusion42's coverage of Diagnostics, and 2 sources have reported it between 6 Aug 2026 and 7 Aug 2026.