Cleared Traditional

C. DIFFICILE TOX A/B II

K030404 · Techlab, Inc. · Microbiology
Apr 2003
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K030404 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 April 24, 2003, 77 days after receiving the submission on February 6, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K030404 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2003
Decision Date April 24, 2003
Days to Decision 77 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