
American Bio Medica Corp.
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RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) is an FDA 510(k)-cleared medical device (K993961) manufactured by American Bio Medica Corp.. 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 23, 2000. Regulation: 8.