OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES is an FDA 510(k)-cleared medical device (K103161) manufactured by Omega Laboratories, Inc.. 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 December 12, 2011. Regulation: 8.