Cleared Traditional

DIRECTIGEN MENINGITIS COMBO TEST KIT

K915330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Mar 1992
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K915330 is an FDA 510(k) clearance for the DIRECTIGEN MENINGITIS COMBO TEST KIT, a Antisera, All Groups, N. Meningitidis (Class II — Special Controls, product code GTJ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 23, 1992, 118 days after receiving the submission on November 26, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K915330 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1991
Decision Date March 23, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTJ — Antisera, All Groups, N. Meningitidis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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