MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test

About This 510(k) Submission

K251040 is an FDA 510(k) clearance for the MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 9, 2025, 159 days after receiving the submission on April 3, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.