510(k) K993954

SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS by Beckman Coulter, Inc. — Product Code DKB

K993954 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS". The FDA issued a decision of Substantially Equivalent on January 11, 2000. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.