ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY

ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY is an FDA 510(k)-cleared medical device (K962673) manufactured by Princeton BioMeditech 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 August 14, 1996. Regulation: 8.