510(k) K120763

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

K120763 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS". The FDA issued a decision of Substantially Equivalent on June 1, 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.