Lumipulse G E2-III Calibrators

Lumipulse G E2-III Calibrators is an FDA 510(k)-cleared medical device (K163053) manufactured by Fujirebio Diagnostics,Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 2016. Regulation: 8.