510(k) K032764

BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) by Lin-Zhi International, Inc. — Product Code DIS

K032764 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)". The FDA issued a decision of Substantially Equivalent on November 3, 2003. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.