PreMD Announces FDA Decision On POC Skin Cholesterol Test
Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) announced that it has received a non-substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. The company expects to evaluate its options as part of the plans to address this issue.
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Filed under: Cholesterol on January 29th, 2008