SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)

SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) is an FDA 510(k)-cleared medical device (K971467) manufactured by Carolina Liquid Chemistries Corp.. 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 15, 1997. Regulation: 8.