IMMULITE OPIATES SCREEN/CONTROL MODULE

IMMULITE OPIATES SCREEN/CONTROL MODULE is an FDA 510(k)-cleared medical device (K962323) 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 March 9, 1997. Regulation: 8.