Cleared Traditional

IMMUNOCARD TOXIN A

K955859 · Meridian Diagnostics, Inc. · Microbiology
Apr 1996
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K955859 is an FDA 510(k) clearance for the IMMUNOCARD TOXIN A, 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 April 18, 1996, 113 days after receiving the submission on December 27, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K955859 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1995
Decision Date April 18, 1996
Days to Decision 113 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