510(k) K893985

HGB-CONTROL SET/MULTIPLE by R&D Systems, Inc. — Product Code GGM

K893985 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "HGB-CONTROL SET/MULTIPLE". The FDA issued a decision of Substantially Equivalent on August 15, 1989. 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.