|By Marketwired .||
|December 24, 2013 08:30 AM EST||
SEATTLE, WA -- (Marketwired) -- 12/24/13 -- Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company, today announced that it has submitted a Premarket 510(k) Notification with the U.S. Food and Drug Administration (FDA) seeking clearance of the ForeCYTE Breast Aspirator, including the ForeCYTE breast pump and patient collection kit, which are intended for use in the collection of nipple aspirate fluid for laboratory cytological testing. In accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act, the agency typically has 90 days to clear the device for commercial distribution, request additional information, or find that the device is not substantially equivalent to the predicate device. Sometimes, FDA's review time may take longer. Upon receiving clearance from the FDA, the Company expects to re-launch its ForeCYTE device.
About Atossa Genetics
Atossa Genetics, Inc. is focused on proprietary products and services related to breast health through the commercialization of medical devices and, through its wholly-owned subsidiary, The National Reference Laboratory for Breast Health, Inc., the offering of laboratory services and tests. For additional information, please visit www.atossagenetics.com.
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, including timing of review by the FDA of 510(k) submissions, and actions related thereto, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors, estimated future expenses and cash needs, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.