
Chemtron Biotech, Inc.
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CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD is an FDA 510(k)-cleared medical device (K111322) manufactured by Chemtron Biotech, 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 September 13, 2011. Regulation: 8.