510(k) K140546

HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST by Healgen Scientific,, LLC — Product Code LDJ

K140546 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on June 6, 2014. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.