
Quest Diagnostics, Inc.
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QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA is an FDA 510(k)-cleared medical device (K062929) manufactured by Quest Diagnostics, 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 December 17, 2006. Regulation: 8.