SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 is an FDA 510(k)-cleared medical device (K983709) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 27, 1998. Regulation: 8.