FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is an FDA 510(k)-cleared medical device (K210623) manufactured by Sebia. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2022. Regulation: 8.