510(k) K904675

QBC SYSTEM MCHC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JPJ

K904675 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "QBC SYSTEM MCHC". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code JPJ (Red-Cell Indices, Calculated), a Class II device regulated under 21 CFR 864.5300. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.