510(k) K010599

PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE by International Technidyne Corp. — Product Code GJS

K010599 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. International Technidyne Corp. has at least 10 other 510(k) clearances on record.