Cleared Traditional

K813431 - SALICYLATES

K813431 is the FDA 510(k) clearance for SALICYLATES by Bio-Analytics Laboratories, Inc.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K813431 · Bio-Analytics Laboratories, Inc. · Toxicology device
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Mar 1982
Decision
107d
Days
Class 2
Risk

K813431 is an FDA 510(k) clearance for the SALICYLATES. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3830 - 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 Bio-Analytics Laboratories, Inc. devices

Submission Details

510(k) Number K813431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1981
Decision Date March 25, 1982
Days to Decision 107 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 87d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKJ Colorimetry, Salicylate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3830
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.