
Helena Laboratories
Free shipping on orders over $99 · 30-day returns
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM is an FDA 510(k)-cleared medical device (K880698) 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 May 5, 1988. Regulation: 8.