510(k) K991551

VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JKA

K991551 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE". The FDA issued a decision of Substantially Equivalent on September 23, 1999. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.