SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS is an FDA 510(k)-cleared medical device (K993022) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 1999. Regulation: 8.