OPIATES MICRO-PLATE ASSAY

OPIATES MICRO-PLATE ASSAY is an FDA 510(k)-cleared medical device (K935565) manufactured by Solarcare Technologies Corp,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 July 13, 1995. Regulation: 8.