Cleared Traditional

C. DIFF CHEK - 30

K030991 · Techlab, Inc. · Microbiology
Jul 2003
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K030991 is an FDA 510(k) clearance for the C. DIFF CHEK - 30, 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 11, 2003, 105 days after receiving the submission on March 28, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K030991 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2003
Decision Date July 11, 2003
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660