510(k) K841308

DIRECTIGEN MENNINGITIS TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTI

K841308 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DIRECTIGEN MENNINGITIS TEST KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code GTI (Antisera, Fluorescent, All Groups, N. Meningitidis), a Class II device regulated under 21 CFR 866.3390. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.