iC-GPC Assay TM for use on the iC-SystemTM

iC-GPC Assay TM for use on the iC-SystemTM is an FDA 510(k)-cleared medical device (K163390) 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 August 7, 2017. Regulation: 8.