510(k) K023316

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS by Lin-Zhi International, Inc. — Product Code DLJ

K023316 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.