510(k) K230238

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx by Shenzhen Bioeasy Biotechnology Co., Ltd. — Product Code DJG

K230238 is an FDA 510(k) premarket notification submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. for the device "BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx". The FDA issued a decision of Substantially Equivalent on March 31, 2023. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Shenzhen Bioeasy Biotechnology Co., Ltd. has at least 4 other 510(k) clearances on record.