COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL is an FDA 510(k)-cleared medical device (K923317) 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 24, 1992. Regulation: 8.