Atossa Warned by FDA Over its MASCT Platform | GenomeWeb

NEW YORK (GenomeWeb News) – Atossa Genetics today disclosed it has been warned by the US Food and Drug Administration over its system for the analysis of nipple aspirate fluid.

In a document filed with the US Securities and Exchange Commission, Atossa said that it received a warning letter from FDA regarding the system called Mammary Aspirate Specimen Cytology Test System, or MASCT, on Feb. 21.

FDA alleges in its warning that after MASCT was cleared by FDA, Atossa made changes to the platform that requires submission of an additional 510(k) notification, Atossa said

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