510(k) K212447

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream by Hangzhou Sejoy Electronics & Instruments Co., Ltd. — Product Code LCX

K212447 is an FDA 510(k) premarket notification submitted by Hangzhou Sejoy Electronics & Instruments Co., Ltd. for the device "SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream". The FDA issued a decision of Substantially Equivalent on Feb 18, 2022. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155.