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Home Diagnostics, Inc.
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TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 is an FDA 510(k)-cleared medical device (K080641) manufactured by Home Diagnostics, 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 August 18, 2008. Regulation: 8.