Atossa Genetics Reports on 510(k) Pre-Submission Meeting With the Food and Drug Administration
(firmenpresse) - SEATTLE, WA -- (Marketwired) -- 11/18/13 -- Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company™, today announced that on November 14, 2013, Atossa attended a pre-510(k) submission meeting with the Food and Drug Administration and discussed the regulatory pathway and data requirements to support Atossa's planned 510(k) Premarket Notification submission for the ForeCYTE Breast Pump and patient kit. Atossa reports that the meeting was productive and will help inform the strategy, content, and timing of the regulatory requirements for the medical device.
Based partially on feedback from the meeting, Atossa plans to submit a 510(k) notification to the FDA related to the ForeCYTE Breast Pump and patient kit. Atossa believes that it has the data and other information to support this submission and intends to file the 510(k) with the FDA as soon as possible. Atossa intends to continue working with the FDA as the 510(k) is prepared, submitted, and reviewed by the FDA for its specific claims.
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 .
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, the feedback from the pre-submission meeting 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.
Atossa Genetics, Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
MBS Value Partners
Matthew D. Haines (Investors and Media)
Managing Director
(O) 212-710-9686
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Datum: 18.11.2013 - 07:30 Uhr
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