510(k) K240920

HemoCare Bicarbonate Concentrate Set (BCS) by Deka Research and Development — Product Code KPO

K240920 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "HemoCare Bicarbonate Concentrate Set (BCS)". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Deka Research and Development has at least 10 other 510(k) clearances on record.