StatStrip Xpress Blood Glucose Monitoring System

StatStrip Xpress Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K170464) manufactured by Nova Biomedical Corporation. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2017. Regulation: 8.