ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS is an FDA 510(k)-cleared medical device (K050024) manufactured by Guangzhou Wondfo Biotech Co., Ltd.. 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 16, 2005. Regulation: 8.