BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay. The Architect Galectin-3 assay, which is designed for use with Abbott's automated ...
Tags: BG Medicine, premarket notification, FDA, Architect Galectin-3 assay
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...