MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT is an FDA 510(k)-cleared medical device (K060896) manufactured by Varian, 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 June 8, 2006. Regulation: 8.