Cleared Traditional

C. DIFF QUIK CHEK COMPLETE

K082499 · Techlab, Inc. · Microbiology
Mar 2009
Decision
209d
Days
Class 1
Risk

About This 510(k) Submission

K082499 is an FDA 510(k) clearance for the C. DIFF QUIK CHEK COMPLETE, 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 March 26, 2009, 209 days after receiving the submission on August 29, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K082499 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2008
Decision Date March 26, 2009
Days to Decision 209 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

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