GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)

GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) is an FDA 510(k)-cleared medical device (K020210) manufactured by Bayer Group Diagnostics. 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 April 29, 2002. Regulation: 8.