DiaDexus Submits 510(k) to FDA for PLAC Test

DiaDexus has announced submission of a 510(k) Premarket Notification to the FDA seeking marketing clearance for the PLAC test as an in vitro diagnostic product to help predict the risk for ischemic stroke. If cleared for marketing, the PLAC test would be the first blood test with an indication for use in assessing stroke risk.

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