SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 is an FDA 510(k)-cleared medical device (K092346) manufactured by Serim Research Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2010. Regulation: 8.