510(k) K141320

LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls by Lin-Zhi International, Inc. — Product Code LDJ

K141320 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.