
Healgen Scientific,, LLC
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Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test is an FDA 510(k)-cleared medical device (K252523) manufactured by Healgen Scientific,, LLC. 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 11, 2026. Regulation: 8.