Atossa Files for FDA Clearance of Recalled Breast Cancer Test | GenomeWeb

NEW YORK (GenomeWeb News) – Atossa Genetics said on Tuesday that it has submitted a premarket 510(k) notification with the US Food and Drug Administration for its ForeCYTE breast cancer test device.

The Seattle-based company voluntarily recalled the device in October after FDA voiced concerns about certain actions by Atossa, including the marketing of the device although FDA had not cleared or approved the ForeCYTE device for any indication.

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