510(k) K071489

HOMECHECK MULTIPLE DRUG CUP TEST by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DKZ

K071489 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "HOMECHECK MULTIPLE DRUG CUP TEST". The FDA issued a decision of Substantially Equivalent on March 28, 2008. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Tianjin New Bay Bioresearch Co., Ltd. has at least 10 other 510(k) clearances on record.