AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 is an FDA 510(k)-cleared medical device (K933086) 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 October 30, 1994. Regulation: 8.