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Lin-Zhi International, Inc.
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BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) is an FDA 510(k)-cleared medical device (K032764) 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 November 2, 2003. Regulation: 8.