
Harleco
Free shipping on orders over $99 · 30-day returns
ULTRACHEM GLUC-DH SET, ITEM #65048 is an FDA 510(k)-cleared medical device (K813042) 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 November 9, 1981. Regulation: 8.