510(k) K120005

ACDS by Isopure, Corp. — Product Code KPO

K120005 is an FDA 510(k) premarket notification submitted by Isopure, Corp. for the device "ACDS". The FDA issued a decision of Substantially Equivalent on March 29, 2012. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Isopure, Corp. has at least 4 other 510(k) clearances on record.