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Tag: de novo classification

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

510(k), de novo classification, FDA, Medical DevicesFDA

On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, …

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Katherine L. Giannamore
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