510(k) K854206

ULTRACLONE 05-100 GUINEA PIG RBC by Earl-Clay Laboratories, Inc. — Product Code KPO

K854206 is an FDA 510(k) premarket notification submitted by Earl-Clay Laboratories, Inc. for the device "ULTRACLONE 05-100 GUINEA PIG RBC". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Earl-Clay Laboratories, Inc. has at least 10 other 510(k) clearances on record.