
Princeton BioMeditech Corp.
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ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 is an FDA 510(k)-cleared medical device (K992422) manufactured by Princeton BioMeditech 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 9, 1999. Regulation: 8.