ELLAGIC ACID APTT REAGENT

ELLAGIC ACID APTT REAGENT is an FDA 510(k)-cleared medical device (K915418) 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 February 13, 1992. Regulation: 8.