MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT is an FDA 510(k)-cleared medical device (K903993) manufactured by Immunotech 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 December 19, 1990. Regulation: 8.