Cleared Traditional

MERITEC C. DIFFICILE CONTROLS

K924062 · Meridian Diagnostics, Inc. · Microbiology
Oct 1992
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K924062 is an FDA 510(k) clearance for the MERITEC C. DIFFICILE CONTROLS, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 19, 1992, 68 days after receiving the submission on August 12, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K924062 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1992
Decision Date October 19, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MCB — Antigen, C. Difficile
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660