510(k) K031797

METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) by Lin-Zhi International, Inc. — Product Code DJR

K031797 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)". The FDA issued a decision of Substantially Equivalent on October 10, 2003. 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.