HELENA SICKLE-THAL QUIK COLUMN METHOD

HELENA SICKLE-THAL QUIK COLUMN METHOD is an FDA 510(k)-cleared medical device (K812077) 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 August 17, 1981. Regulation: 8.