
Abbott Laboratories
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REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. is an FDA 510(k)-cleared medical device (K880013) manufactured by Abbott Laboratories. 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 February 29, 1988. Regulation: 8.