510(k) K241394

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip by Andon Health Co, Ltd. — Product Code LCX

K241394 is an FDA 510(k) premarket notification submitted by Andon Health Co, Ltd. for the device "iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Andon Health Co, Ltd. has at least 10 other 510(k) clearances on record.