HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL

HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL is an FDA 510(k)-cleared medical device (K820787) 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 7, 1982. Regulation: 8.