510(k) K163704

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card by Healgen Scientific,, LLC — Product Code JXM

K163704 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card". The FDA issued a decision of Substantially Equivalent on August 2, 2017. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.