510(k) K153050

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard by Co-Innovation Biotech Co., Ltd. — Product Code DJG

K153050 is an FDA 510(k) premarket notification submitted by Co-Innovation Biotech Co., Ltd. for the device "Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard". The FDA issued a decision of Substantially Equivalent on April 26, 2016. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Co-Innovation Biotech Co., Ltd. has at least 9 other 510(k) clearances on record.