510(k) K093243

COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM by Coagusense, Inc. — Product Code GJS

K093243 is an FDA 510(k) premarket notification submitted by Coagusense, Inc. for the device "COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 7, 2010. 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.