510(k) K070334

R&D SICKLE QC CONTROL by R&D Systems, Inc. — Product Code GGM

K070334 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "R&D SICKLE QC CONTROL". The FDA issued a decision of Substantially Equivalent on March 29, 2007. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.