510(k) K141388

SYSTEM CALIBRATER by Beckman Coulter Ireland, Inc. — Product Code JIX

K141388 is an FDA 510(k) premarket notification submitted by Beckman Coulter Ireland, Inc. for the device "SYSTEM CALIBRATER". The FDA issued a decision of Substantially Equivalent on July 11, 2014. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Beckman Coulter Ireland, Inc. has at least 6 other 510(k) clearances on record.