ABUSCREEN ONLINE(R) CALIBRATORS

ABUSCREEN ONLINE(R) CALIBRATORS is an FDA 510(k)-cleared medical device (K931124) 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 August 2, 1993. Regulation: 8.