510(k) K191245

Yumizen C1200 ALP, Yumizen C1200 Albumin by HORIBA ABX SAS — Product Code CJE

K191245 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "Yumizen C1200 ALP, Yumizen C1200 Albumin". The FDA issued a decision of Substantially Equivalent on August 30, 2019. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.