
Harleco
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ULTRACHEM GLUC-DH, ITEM NO. 65048 is an FDA 510(k)-cleared medical device (K811202) manufactured by Harleco. 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 May 26, 1981. Regulation: 8.