Cleared Traditional

PREMIER C. DIFFICILE, MODIFICATION

K926442 · Meridian Diagnostics, Inc. · Microbiology
Jan 1993
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K926442 is an FDA 510(k) clearance for the PREMIER C. DIFFICILE, MODIFICATION, 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 27, 1993, 42 days after receiving the submission on December 16, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K926442 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1992
Decision Date January 27, 1993
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660