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American Bio Medica Corp.
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'RAPID ONE' - PROPOXYPHENE TEST is an FDA 510(k)-cleared medical device (K030835) 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 May 21, 2003. Regulation: 8.