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Immunalysis Corporation
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RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] is an FDA 510(k)-cleared medical device (K871549) manufactured by Immunalysis Corporation. 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 15, 1987. Regulation: 8.