510(k) K131653

LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS by Lin-Zhi International, Inc. — Product Code DKZ

K131653 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS". The FDA issued a decision of Substantially Equivalent on February 4, 2014. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.