Cleared Traditional

PREMIER C. DIFFICILE GDH

K110620 · Meridian Bioscience, Inc. · Microbiology
May 2011
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K110620 is an FDA 510(k) clearance for the PREMIER C. DIFFICILE GDH, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 3, 2011, 61 days after receiving the submission on March 3, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K110620 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2011
Decision Date May 03, 2011
Days to Decision 61 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
VIDAS C DIFFICILE GDH
K132010 · Biomerieux S.A. · Oct 2013
IMMUNOCARD C. DIFFICILE GDH
K112048 · Meridian Bioscience, Inc. · Dec 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