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This article was originally published in The Gray Sheet
Boehringer Mannheim Corp.: Submits 510(k) to FDA for an expansion of labeling for its CoaguChek prothrombin time (PT) test system to include patient self-testing. The system has been marketed for professional use since August 1993 and has been in trials for more than a year for the home-use indication ("The Gray Sheet" May 6, 1996, I&W-4)...
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