Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is an FDA 510(k)-cleared medical device (K153692) 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 June 23, 2016. Regulation: 8.