SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I is an FDA 510(k)-cleared medical device (K983209) 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 3, 1998. Regulation: 8.