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Ameditech, Inc.
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AMEDITECH IMMUTEST DRUG SCREEN THC is an FDA 510(k)-cleared medical device (K011813) manufactured by Ameditech, 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 October 21, 2001. Regulation: 8.