Corgenix Files Pre-Market Notification for FDA Clearance of Hyaluronic Acid Test Kit

Corgenix Medical Corporation

announced today it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for its Hyaluronic Acid (HA) ELISA Test Kit. The submission follows the completion of a clinical study conducted by Corgenix and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under a cooperative research and development agreement (CRADA). The study assessed the Corgenix Hyaluronic Acid (HA) Test Kit as a marker for liver fibrosis in nonalcoholic steatohepatitis (NASH)