COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 is an FDA 510(k)-cleared medical device (K874808) manufactured by Diagnostic Products Corp.. 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 February 17, 1988. Regulation: 8.