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Accu-Stat Diagnostics, Inc.
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ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY is an FDA 510(k)-cleared medical device (K041221) manufactured by Accu-Stat Diagnostics, Inc.. 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 July 12, 2004. Regulation: 8.
