Cleared Traditional

ON-SITE ALCOHOL (K903223) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903223 · Toxi-Lab, Inc. · Toxicology device
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Mar 1991
Decision
233d
Days
Class 2
Risk

K903223 is an FDA 510(k) clearance for the ON-SITE ALCOHOL. Classified as Potassium Dichromate, Alcohol (product code DOJ), Class II - Special Controls.

Submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on March 13, 1991 after a review of 233 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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.

View all Toxi-Lab, Inc. devices

Submission Details

510(k) Number K903223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date March 13, 1991
Days to Decision 233 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 87d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DOJ Potassium Dichromate, Alcohol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.