510(k) K233624

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx by Hangzhou Aichek Medical Technology Co., Ltd. — Product Code LCX

K233624 is an FDA 510(k) premarket notification submitted by Hangzhou Aichek Medical Technology Co., Ltd. for the device "HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx". The FDA issued a decision of Substantially Equivalent on April 12, 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.