iC-GN iC-Cassette for use on the iC-System

iC-GN iC-Cassette for use on the iC-System is an FDA 510(k)-cleared medical device (K190341) manufactured by Icubate, 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 June 27, 2019. Regulation: 8.