510(k) for HemaSure's blood filtration system:
This article was originally published in Clinica
Executive Summary
The US FDA has given marketing clearance to HemaSure's r\LS red blood cell filtration system. The device is designed to reduce the level of leukocytes in donated blood to prevent the transmission of bacteria and viruses to the blood transfusion patient. The CE-marked system will be distributed by Gambro subsidiary COBE.