510(k) K993321

R&D HGB/GLC WHOLE BLOOD CONTROL by R&D Systems, Inc. — Product Code GGM

K993321 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "R&D HGB/GLC WHOLE BLOOD CONTROL". The FDA issued a decision of Substantially Equivalent on November 12, 1999. 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.