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Genexel-Sein, Inc.
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DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM is an FDA 510(k)-cleared medical device (K080853) manufactured by Genexel-Sein, 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 February 19, 2009. Regulation: 8.