510(k) K040866

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST by Armkel, LLC — Product Code LCX

K040866 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on October 19, 2004. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Armkel, LLC has at least 10 other 510(k) clearances on record.