510(k) K821266

BBL DIRECTIGEN MENINGITIS TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GRP

K821266 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BBL DIRECTIGEN MENINGITIS TEST KIT". The FDA issued a decision of Substantially Equivalent on June 1, 1982. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.