510(k) K110239

LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL by Lin-Zhi International, Inc. — Product Code LDJ

K110239 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL". The FDA issued a decision of Substantially Equivalent on June 23, 2011. 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.