510(k) K012328

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER by Di-Chem, Inc. — Product Code KPO

K012328 is an FDA 510(k) premarket notification submitted by Di-Chem, Inc. for the device "HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER". The FDA issued a decision of Substantially Equivalent on January 18, 2002. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Di-Chem, Inc. has at least 5 other 510(k) clearances on record.