510(k) K051058

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

K051058 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on March 29, 2006. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.