
American Bio Medica Corp.
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MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL is an FDA 510(k)-cleared medical device (K992033) 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 June 29, 1999. Regulation: 8.