510(k) K183375

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode by Horiba, Ltd. — Product Code JJE

K183375 is an FDA 510(k) premarket notification submitted by Horiba, Ltd. for the device "Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode". The FDA issued a decision of Substantially Equivalent on February 12, 2019. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Horiba, Ltd. has at least 1 other 510(k) clearance on record.