BioFire JI Control Panel M420

BioFire JI Control Panel M420 is an FDA 510(k)-cleared medical device (K203680) manufactured by Maine Molecular Quality Controls, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2022. Regulation: 8.