510(k) K131652

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

K131652 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS". The FDA issued a decision of Substantially Equivalent on March 21, 2014. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.