Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is an FDA 510(k)-cleared medical device (K212779) manufactured by Coagusense, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2022. Regulation: 8.