510(k) K931756

QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS by R&D Systems, Inc. — Product Code GGT

K931756 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.