HELENA THROMBOPLASTIN-MI REAGENT

HELENA THROMBOPLASTIN-MI REAGENT is an FDA 510(k)-cleared medical device (K940310) 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 April 19, 1994. Regulation: 8.