510(k) K033885

BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) by Lin-Zhi International, Inc. — Product Code DIS

K033885 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)". The FDA issued a decision of Substantially Equivalent on May 19, 2004. 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.