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Roche Diagnostics Corp.
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ONTRAK TESTCUP 501, MODEL 3016633 is an FDA 510(k)-cleared medical device (K001421) manufactured by Roche Diagnostics Corp.. 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 July 11, 2000. Regulation: 8.