510(k) K251634

LZI Fentanyl III Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code DJG

K251634 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Fentanyl III Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.