510(k) K221652

NIKKICART by Renal Care Dialysis Solutions, S.A. DE C.V. — Product Code KPO

K221652 is an FDA 510(k) premarket notification submitted by Renal Care Dialysis Solutions, S.A. DE C.V. for the device "NIKKICART". The FDA issued a decision of Substantially Equivalent on March 3, 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.