ROCKET REFERENCE PLASMA, CAT NO. 5188

ROCKET REFERENCE PLASMA, CAT NO. 5188 is an FDA 510(k)-cleared medical device (K900019) 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 January 24, 1990. Regulation: 8.