Cleared Traditional

C. DIFF QUIK CHEK

K053572 · Techlab, Inc. · Microbiology
Apr 2006
Decision
125d
Days
Class 1
Risk

About This 510(k) Submission

K053572 is an FDA 510(k) clearance for the C. DIFF QUIK CHEK, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 26, 2006, 125 days after receiving the submission on December 22, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K053572 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2005
Decision Date April 26, 2006
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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