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Tokyo Boeki Medisys, Inc.
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PRESTIGE 24I; BIOLIS 24I; MGC 240 is an FDA 510(k)-cleared medical device (K103531) manufactured by Tokyo Boeki Medisys, 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 30, 2011. Regulation: 8.