Cleared Traditional

VIDAS C DIFFICILE GDH

K132010 · Biomerieux S.A. · Microbiology
Oct 2013
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K132010 is an FDA 510(k) clearance for the VIDAS C DIFFICILE GDH, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on October 9, 2013, 100 days after receiving the submission on July 1, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K132010 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2013
Decision Date October 09, 2013
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MCB — Antigen, C. Difficile
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

Similar Devices — MCB Antigen, C. Difficile

All 9
IMMUNOCARD C. DIFFICILE GDH
K112048 · Meridian Bioscience, Inc. · Dec 2011
PREMIER C. DIFFICILE GDH
K110620 · Meridian Bioscience, Inc. · May 2011
C. DIFF QUIK CHEK
K053572 · Techlab, Inc. · Apr 2006
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · Biosite Incorporated · Mar 1998
CLEARVIEW C. DIFF A
K955067 · Unipath , Ltd. · Sep 1996
MERITEC C. DIFFICILE CONTROLS
K924062 · Meridian Diagnostics, Inc. · Oct 1992