AutoCyte PREP data accepted by FDA:
This article was originally published in Clinica
AutoCyte has announced that the US FDA has completed its review of the clinical data in support of the company's premarket approval application for its PREP automated cervical cytology sample preparation device. The company originally submitted a PMA application in the middle of 1998, but the agency subsequently asked for more information. An amended PMA application was filed at the end of 1998. The AutoCyte PREP is one component of an integrated system that also comprises the AutoCyte SCREEN computerised image analysis system and is already sold outside the US.
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