Cleared Traditional

TOX A/B TEST

K971182 · Techlab, Inc. · Microbiology
Jul 1997
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K971182 is an FDA 510(k) clearance for the TOX A/B TEST, 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 22, 1997, 113 days after receiving the submission on March 31, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K971182 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1997
Decision Date July 22, 1997
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