Cleared Traditional

IMMUNOCARD(TM) C. DIFFICILE

K924979 · Meridian Diagnostics, Inc. · Microbiology
Jan 1993
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K924979 is an FDA 510(k) clearance for the IMMUNOCARD(TM) C. DIFFICILE, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 26, 1993, 117 days after receiving the submission on October 1, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K924979 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1992
Decision Date January 26, 1993
Days to Decision 117 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