510(k) K023795

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) by Lin-Zhi International, Inc. — Product Code JXN

K023795 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)". The FDA issued a decision of Substantially Equivalent on January 21, 2003. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.