Beckman Coulter’s Early Sepsis Indicator gets 510(k) clearance
April 22, 2019—Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. The Early Sepsis Indicator is a hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or who are at an increased risk of developing sepsis and is reported automatically as part of a routine CBC with differential test.