Cleared Traditional

DE-TOX TUBES A AND DE-TOX TUBES B (K904326) - FDA 510(k) Clearance

Class I Toxicology device.

K904326 · Dyna-Tek Industries · Toxicology device
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Jan 1991
Decision
119d
Days
Class 1
Risk

K904326 is an FDA 510(k) clearance for the DE-TOX TUBES A AND DE-TOX TUBES B. Classified as Apparatus, General Use, Thin Layer Chromatography (product code DPA), Class I - General Controls.

Submitted by Dyna-Tek Industries (Lenexa, US). The FDA issued a Cleared decision on January 17, 1991 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2270 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K904326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date January 17, 1991
Days to Decision 119 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 87d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPA Apparatus, General Use, Thin Layer Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2270
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.