HELENA THROMBOPLASTIN REAGENT WITH DILUENT

HELENA THROMBOPLASTIN REAGENT WITH DILUENT is an FDA 510(k)-cleared medical device (K905807) 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 15, 1991. Regulation: 8.