Lumipulse G FSH-N Calibrators

Lumipulse G FSH-N Calibrators is an FDA 510(k)-cleared medical device (K163534) 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 12, 2017. Regulation: 8.