510(k) K243365

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup by Healgen Scientific,, LLC — Product Code NGL

K243365 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup". The FDA issued a decision of Substantially Equivalent on December 17, 2024. 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.