
Chemtron Biotech, Inc.
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CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS is an FDA 510(k)-cleared medical device (K102203) 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 January 19, 2011. Regulation: 8.