510(k) K893984

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

K893984 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "HGB-CAL SET/MULTIPLE". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.