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Phamatech, Inc.
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AT HOME DRUG TEST MODELS, 9308T AND 9308X is an FDA 510(k)-cleared medical device (K070009) manufactured by Phamatech, 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 December 6, 2007. Regulation: 8.