THROMBOPLASTIN-LI REAGENT

THROMBOPLASTIN-LI REAGENT is an FDA 510(k)-cleared medical device (K951820) 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 October 19, 1995. Regulation: 8.