CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)

CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) is an FDA 510(k)-cleared medical device (K140089) 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 April 7, 2014. Regulation: 8.