Cleared Traditional

K050891: TOX A/B QUICK CHEK

K050891 · Techlab, Inc. · Microbiology

Jul 2005

Decision

108d

Days

Class 1

Risk

About This 510(k) Submission

K050891 is an FDA 510(k) clearance for the TOX A/B QUICK CHEK, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on July 25, 2005, 108 days after receiving the submission on April 8, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K050891 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2005
Decision Date	July 25, 2005
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF