
Healgen Scientific,, LLC
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HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST is an FDA 510(k)-cleared medical device (K140546) 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 June 5, 2014. Regulation: 8.