510(k) K120761

LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS by Lin-Zhi International, Inc. — Product Code DJG

K120761 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS". The FDA issued a decision of Substantially Equivalent on May 8, 2012. 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.