Cleared Special

C. DIFFICILE TOX A/B II

K003306 · Techlab, Inc. · Microbiology
Nov 2000
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K003306 is an FDA 510(k) clearance for the C. DIFFICILE TOX A/B II, 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 November 22, 2000, 33 days after receiving the submission on October 20, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K003306 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2000
Decision Date November 22, 2000
Days to Decision 33 days
Submission Type Special
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