
American Bio Medica Corp.
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'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME is an FDA 510(k)-cleared medical device (K981705) 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 August 26, 1998. Regulation: 8.