
Sebia
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FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is an FDA 510(k)-cleared medical device (K231601) 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 February 22, 2024. Regulation: 8.