MissLan? Pregnancy Rapid Test (Strip), MissLan? Pregnancy Rapid Test (Midstream)

About This 510(k) Submission

K230038 is an FDA 510(k) clearance for the MissLan? Pregnancy Rapid Test (Strip), MissLan? Pregnancy Rapid Test (Midstream), 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 February 28, 2023, 53 days after receiving the submission on January 6, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.