510(k) K811637

RUBELLA LATEX CARD TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DOK

K811637 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "RUBELLA LATEX CARD TEST". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code DOK (Free Radical Assay, Morphine), a Class II device regulated under 21 CFR 862.3640. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.