LABELING CHANGES COAT-A-COUNT METHADONE IN URINE

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE is an FDA 510(k)-cleared medical device (K873750) 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 October 14, 1987. Regulation: 8.