510(k) K170416

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators by Lin-Zhi International, Inc. — Product Code DJR

K170416 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators". The FDA issued a decision of Substantially Equivalent on June 26, 2017. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.