510(k) K894943

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 by Amgen, Inc. — Product Code GGT

K894943 is an FDA 510(k) premarket notification submitted by Amgen, Inc. for the device "CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3". The FDA issued a decision of Substantially Equivalent on October 10, 1989. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Amgen, Inc. has at least 1 other 510(k) clearance on record.