FDA Product Code DJC: Thin Layer Chromatography, Methamphetamine
Leading manufacturers include Hangzhou Laihe Biotech Co., Ltd. and Healgen Scientific, LLC.
FDA 510(k) Cleared Thin Layer Chromatography, Methamphetamine Devices (Product Code DJC)
About Product Code DJC - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code DJC since 1978, with 31 receiving FDA clearance (average review time: 133 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DJC have taken an average of 262 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.
DJC devices are reviewed by the Toxicology panel. Browse all Toxicology devices →