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Akers Biosciences, Inc.
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MODIFICATION TO: INSTAREAD LITHIUM SYSTEM is an FDA 510(k)-cleared medical device (K050338) manufactured by Akers Biosciences, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 2005. Regulation: 8.