510(k) K232597

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) by Hangzhou Laihe Biotech Co., Ltd. — Product Code DJG

K232597 is an FDA 510(k) premarket notification submitted by Hangzhou Laihe Biotech Co., Ltd. for the device "LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)". The FDA issued a decision of Substantially Equivalent on January 9, 2024. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Hangzhou Laihe Biotech Co., Ltd. has at least 2 other 510(k) clearances on record.