
Lin-Zhi International, Inc.
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LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is an FDA 510(k)-cleared medical device (K170416) manufactured by Lin-Zhi International, 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 25, 2017. Regulation: 8.