510(k) K192299

LZI Cotinine II Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code MKU

K192299 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Cotinine II Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on November 21, 2019. The device falls under product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites), a Class I device regulated under 21 CFR 862.3220. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.