Tag Archive: medical mobile app

May 29

FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The uChek Urine Analyzer is an iPhone mobile app, intended for use with Siemens and Bayer …

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