Cleared Traditional

K082499 - C. DIFF QUIK CHEK COMPLETE (FDA 510(k) Clearance)

Class I Microbiology device.

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

K082499 is an FDA 510(k) clearance for the C. DIFF QUIK CHEK COMPLETE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K082499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 174d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLH Reagents, Clostridium Difficile Toxin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.