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Jas Diagnostics, Inc.
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DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID is an FDA 510(k)-cleared medical device (K080618) manufactured by Jas Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 2008. Regulation: 8.