The FDA is asking Biosense Technologies why the company did not submit its mobile application, the uChek Urine Analyzer, to the agency for 510(k) clearance. The app uses a mobile phone to analyze urine using test strips manufactured by Siemens and Bayer that have received FDA clearance. In a letter, the agency, which in the past has said it will regulate mobile apps selectively, asked Biosense to explain why it did not submit its app for clearance or identify an existing FDA clearance for it.

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