510(k) K212779

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing by Coagusense, Inc. — Product Code GJS

K212779 is an FDA 510(k) premarket notification submitted by Coagusense, Inc. for the device "Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing". The FDA issued a decision of Substantially Equivalent on October 5, 2022. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Coagusense, Inc. has at least 2 other 510(k) clearances on record.