510(k) K042990

FOR SURE ONE STEP BUPRENORPHINE TEST STRIP by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DJG

K042990 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "FOR SURE ONE STEP BUPRENORPHINE TEST STRIP". The FDA issued a decision of Substantially Equivalent on May 10, 2005. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Tianjin New Bay Bioresearch Co., Ltd. has at least 10 other 510(k) clearances on record.