510(k) K034048

R&D GLU-LINE HEMATOLOGY CONTROL by R&D Systems, Inc. — Product Code JJX

K034048 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "R&D GLU-LINE HEMATOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.