510(k) K141055

LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) by Lin-Zhi International, Inc. — Product Code DJG

K141055 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)". The FDA issued a decision of Substantially Equivalent on June 13, 2014. 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.