StatStrip Xpress 2 Glucose Hospital Meter System

StatStrip Xpress 2 Glucose Hospital Meter System is an FDA 510(k)-cleared medical device (K152986) 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 January 26, 2016. Regulation: 8.