510(k) K253567

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card by Healgen Scientific,, LLC — Product Code NGL

K253567 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.