510(k) K240287

LYHER® Oral fluid Multi-Drug Test Kit (Cube) by Hangzhou Laihe Biotech Co., Ltd. — Product Code DJC

K240287 is an FDA 510(k) premarket notification submitted by Hangzhou Laihe Biotech Co., Ltd. for the device "LYHER® Oral fluid Multi-Drug Test Kit (Cube)". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Hangzhou Laihe Biotech Co., Ltd. has at least 2 other 510(k) clearances on record.