
Varian, Inc.
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VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK is an FDA 510(k)-cleared medical device (K033659) 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 5, 2004. Regulation: 8.