Synermed ISE Reagents

Synermed ISE Reagents is an FDA 510(k)-cleared medical device (K181201) manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). 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 July 9, 2018. Regulation: 8.