Lumipulse G Prolactin

Lumipulse G Prolactin is an FDA 510(k)-cleared medical device (K163544) 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 January 11, 2017. Regulation: 8.