510(k) K212620

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KPO

K212620 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate". The FDA issued a decision of Substantially Equivalent on May 12, 2022. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.