510(k) K193480

BIOEASY Multi-Drug Test Cup by Shenzhen Bioeasy Biotechnology Co., Ltd. — Product Code NGL

K193480 is an FDA 510(k) premarket notification submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. for the device "BIOEASY Multi-Drug Test Cup". The FDA issued a decision of Substantially Equivalent on January 31, 2020. The device falls under product code NGL (Test, Opiates, Over The Counter), 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.