510(k) K832228

RUBASCAN LATEX CARD TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GOK

K832228 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "RUBASCAN LATEX CARD TEST". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code GOK (Antisera, Hai (Including Hai Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.