FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
Leading manufacturers include Guangzhou Decheng Biotechnology Co., Ltd., Hangzhou AllTest Biotech Co., Ltd. and Assure Tech., LLC.
FDA 510(k) Cleared Kit, Test, Pregnancy, Hcg, Over The Counter Devices (Product Code LCX)
About Product Code LCX - Regulatory Context
510(k) Submission Activity
226 total 510(k) submissions under product code LCX since 1978, with 226 receiving FDA clearance (average review time: 104 days).
Submission volume has remained relatively stable over the observed period, with 10 submissions in the last 24 months.
FDA Review Time
Recent submissions under LCX have taken an average of 143 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.
LCX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →