510(k) K140748

ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD by Co-Innovation Biotech Co., Ltd. — Product Code DJG

K140748 is an FDA 510(k) premarket notification submitted by Co-Innovation Biotech Co., Ltd. for the device "ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD". The FDA issued a decision of Substantially Equivalent on August 20, 2014. 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.