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Polymer Technology OTC Triglyceride Test Performance Data Insufficient

This article was originally published in The Gray Sheet

Executive Summary

Polymer Technology Systems, Inc., should generate data demonstrating that its MTM BioScanner 2000 test strips intended for over-the-counter triglyceride testing comply with performance thresholds set by the National Cholesterol Education Project, FDA's Clinical Chemistry and Clinical Toxicology Devices Panel concluded at an Oct. 28 meeting.
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