MissLan? Early Detection Pregnancy Test Strip; MissLan? Early Detection Pregnancy Test Cassette; MissLan? Early Detection Pregnancy Test Midstream

About This 510(k) Submission

K240643 is an FDA 510(k) clearance for the MissLan? Early Detection Pregnancy Test Strip; MissLan? Early Detection Pregnancy Test Cassette; MissLan? Early Detection Pregnancy 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 June 21, 2024, 106 days after receiving the submission on March 7, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.