510(k) K062242

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

K062242 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on September 29, 2006. 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.