LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS

About This 510(k) Submission

K120763 is an FDA 510(k) clearance for the LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 1, 2012, 80 days after receiving the submission on March 13, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.