510(k) K920274

DIRECTIGEN NEISSERIA MENINGITIDIS TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTI

K920274 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DIRECTIGEN NEISSERIA MENINGITIDIS TEST". The FDA issued a decision of Substantially Equivalent on March 18, 1992. 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.