510(k) K223431

Citric Complete Liquid Citric Acid Concentrate by Nipro Renal Solutions USA, Corp. — Product Code KPO

K223431 is an FDA 510(k) premarket notification submitted by Nipro Renal Solutions USA, Corp. for the device "Citric Complete Liquid Citric Acid Concentrate". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Nipro Renal Solutions USA, Corp. has at least 1 other 510(k) clearance on record.