510(k) K112449

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST by Tianjin New Bay Bioresearch Co., Ltd. — Product Code LCX

K112449 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST". The FDA issued a decision of Substantially Equivalent on September 24, 2012. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Tianjin New Bay Bioresearch Co., Ltd. has at least 10 other 510(k) clearances on record.