FDA Wants More Info From Atossa Genetics, Inc. For Forecyte Breast Aspirator
Published: Mar 04, 2014
Atossa Genetics Inc. Announces FDA Response to 510(k) Submission for ForeCYTE Breast Aspirator
SEATTLE, WA--(Marketwired - Mar 4, 2014) - Atossa Genetics Inc. (NASDAQ: ATOS) announced today that it has received a request for additional information from the U.S. Food and Drug Administration (FDA) related to its 510(k) application for the ForeCYTE Breast Aspirator. Atossa plans to request an extension to the 30 day time limit by which a response must be provided to the FDA. If the request for an extension is granted, Atossa will have up to 180 days to provide a response to the FDA's questions. Atossa does not view the FDA's request for additional information as unusual or unexpected and will continue to work toward final clearance of the submission.
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, whether Atossa can submit additional information to the FDA in a timely fashion and whether the FDA will find that information acceptable and/or request additional information, 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, 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.
CFO and General Counsel
MBS Value Partners
Matthew D. Haines (Investors and Media)
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