ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED

ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED is an FDA 510(k)-cleared medical device (K933052) manufactured by Roche Diagnostic Systems, 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 September 14, 1993. Regulation: 8.