
Abbott Diabetes Care, Inc.
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RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) is an FDA 510(k)-cleared medical device (K081975) manufactured by Abbott Diabetes Care, Inc.. 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 25, 2008. Regulation: 8.