GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) is an FDA 510(k)-cleared medical device (K020208) 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 28, 2002. Regulation: 8.