FilmArray RP EZ Control Panel M265

FilmArray RP EZ Control Panel M265 is an FDA 510(k)-cleared medical device (K161573) 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 September 1, 2016. Regulation: 8.