Cleared Traditional

VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY

K080931 · bioMerieux, Inc. · Microbiology
Jun 2008
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K080931 is an FDA 510(k) clearance for the VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 11, 2008, 70 days after receiving the submission on April 2, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K080931 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2008
Decision Date June 11, 2008
Days to Decision 70 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