METHAQUALONE ENZYME IMMUNOASSAY

METHAQUALONE ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K940123) manufactured by Diagnostic Reagents, 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 May 2, 1994. Regulation: 8.