510(k) K192209

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

K192209 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate". The FDA issued a decision of Substantially Equivalent on May 8, 2020. 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.