
Lin-Zhi International, Inc.
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AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) is an FDA 510(k)-cleared medical device (K020395) 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 3, 2002. Regulation: 8.