510(k) K123567

FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST by Church & Dwight Co., Inc. — Product Code LCX

K123567 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on September 10, 2013. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.