510(k) K153597

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

K153597 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 May 23, 2016. 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.