
King Diagnostics, Inc.
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KING DIAGNOSTICS GLUCOSE (HK) REAGENT is an FDA 510(k)-cleared medical device (K923129) manufactured by King 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 November 1, 1992. Regulation: 8.