Eyeing 2014 FDA Submission for Unyvero System, Curetis Starts Clinical Trial | GenomeWeb

NEW YORK (GenomeWeb News) – German molecular diagnostics company Curetis said today it anticipates filing a 510(k) submission with the US Food and Drug Administration for its Unyvero System in 2014.

In preparation of a submission, the company has begun a clinical trial for the system and its lower respiratory tract (LRT) application. Curetis expects the trial to last between 12 and 15 months.

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