AGGLUTEX AMPHETAMINE TEST KIT

AGGLUTEX AMPHETAMINE TEST KIT is an FDA 510(k)-cleared medical device (K812986) manufactured by Hoffmann-La Roche, 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 January 21, 1982. Regulation: 8.