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Tag: intended use

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

510(k), Disease Claims, FDA, intended use, Medical Devices, medical mobile appFDA

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 …

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