510(k) K052520

RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DJG

K052520 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC". The FDA issued a decision of Substantially Equivalent on April 24, 2006. 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.