International Technidyne gains clearance for first home-use PT test; ProTime to list for $2,000.
This article was originally published in The Gray Sheet
Executive SummaryITC TO LAUNCH PROTIME HOME-USE PT TEST IN NEXT FEW WEEKS at a list price of $2,000. Edison, New Jersey-based International Technidyne Corporation, a wholly owned subsidiary of Thermo Electron, received 510(k) clearance from FDA March 12 to market the hand-held prothrombin time test for use at home by patients undergoing treatment with the blood- thinning drug warfarin.
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