K120761 - LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
(FDA 510(k) Clearance)

K120761 is an FDA 510(k) clearance for the LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 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 May 8, 2012, 56 days after receiving the submission on March 13, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.