FDA 510(k), K093243, COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

FDA 510(k), K093243, COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

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510(K) Number: K093243
Device Name: COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Manufacturer: COAGUSENSE, INC
Device Classification Name: Test, Time, Prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 10/15/2009
Decision Date: 04/07/2010
Regulation Medical Specialty: Hematology

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