Cleared Traditional

IMMUNOCARD C. DIFFICILE GDH

K112048 · Meridian Bioscience, Inc. · Microbiology

Dec 2011

Decision

151d

Days

Class 1

Risk

About This 510(k) Submission

K112048 is an FDA 510(k) clearance for the IMMUNOCARD 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 December 16, 2011, 151 days after receiving the submission on July 18, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K112048 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2011
Decision Date	December 16, 2011
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF