510(k) K142346

Urine/CSF Albumin, Urine/CSF Albumin Calibrator by Beckman Coulter Ireland, Inc. — Product Code DCF

K142346 is an FDA 510(k) premarket notification submitted by Beckman Coulter Ireland, Inc. for the device "Urine/CSF Albumin, Urine/CSF Albumin Calibrator". The FDA issued a decision of Substantially Equivalent on October 15, 2014. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Beckman Coulter Ireland, Inc. has at least 6 other 510(k) clearances on record.