510(k) K843695

QCA HEMOGLOBIN KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KRZ

K843695 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "QCA HEMOGLOBIN KIT". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.