
Helena Laboratories
Free shipping on orders over $99 · 30-day returns
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) is an FDA 510(k)-cleared medical device (K900017) manufactured by Helena Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 1990. Regulation: 8.