510(k) K050988

OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS by Lin-Zhi International, Inc. — Product Code DLG

K050988 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on April 6, 2006. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.