510(k) K232228

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card by Shanghai Accurature Diagnostics Co., Ltd. — Product Code DJG

K232228 is an FDA 510(k) premarket notification submitted by Shanghai Accurature Diagnostics Co., Ltd. for the device "Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650.