510(k) K240643

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code LCX

K240643 is an FDA 510(k) premarket notification submitted by Guangzhou Decheng Biotechnology Co., Ltd. for the device "MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream". The FDA issued a decision of Substantially Equivalent on June 21, 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. Guangzhou Decheng Biotechnology Co., Ltd. has at least 7 other 510(k) clearances on record.