Cleared Traditional

SLIDEX MENINGITE-KIT 5

K910210 · Vitek Systems, Inc. · Microbiology
Aug 1991
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K910210 is an FDA 510(k) clearance for the SLIDEX MENINGITE-KIT 5, a Antisera, All Groups, N. Meningitidis (Class II — Special Controls, product code GTJ), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 12, 1991, 209 days after receiving the submission on January 15, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K910210 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1991
Decision Date August 12, 1991
Days to Decision 209 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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