510(k) K051088

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

K051088 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on June 24, 2005. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.