SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268

SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 is an FDA 510(k)-cleared medical device (K091815) manufactured by Biotest Medical Corp.. 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 15, 2009. Regulation: 8.