ONTRAK TESTCUP II AND ONSITE CUPKIT

ONTRAK TESTCUP II AND ONSITE CUPKIT is an FDA 510(k)-cleared medical device (K033902) 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 January 19, 2004. Regulation: 8.