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Ameditech, Inc.
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AMEDITECH IMMU TEST DRUG SCREEN PANEL is an FDA 510(k)-cleared medical device (K040092) 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 March 7, 2004. Regulation: 8.