
Trace America, Inc.
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GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is an FDA 510(k)-cleared medical device (K980026) manufactured by Trace America, 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 March 9, 1998. Regulation: 8.