Cleared Traditional

VIDAS C. DIFFICILE TOXIN A II ASSAY

K964887 · Biomerieux Vitek, Inc. · Microbiology
Apr 1997
Decision
123d
Days
Class 1
Risk

About This 510(k) Submission

K964887 is an FDA 510(k) clearance for the VIDAS C. DIFFICILE TOXIN A II ASSAY, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on April 8, 1997, 123 days after receiving the submission on December 6, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K964887 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1996
Decision Date April 08, 1997
Days to Decision 123 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660