
Arkray Factory USA, Inc.
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ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K092104) manufactured by Arkray Factory USA, 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 23, 2009. Regulation: 8.