AGGLUTEX METHAQUALONE TEST KIT

AGGLUTEX METHAQUALONE TEST KIT is an FDA 510(k)-cleared medical device (K812987) 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 December 21, 1981. Regulation: 8.