CAPI 3 HEMOGLOBIN(E)

CAPI 3 HEMOGLOBIN(E) is an FDA 510(k)-cleared medical device (K180762) manufactured by Sebia. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2018. Regulation: 8.