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Salicylates (K813431)

by Bio-Analytics Laboratories, Inc. 510(k)

Active United States

510(k) K813431

Overview

This device is a colorimetric assay for the quantitative determination of salicylates in biological samples, classified under the nomenclature for toxicology testing. It employs chemical reactions to measure salicylate concentrations, aiding in clinical toxicology assessments to evaluate exposure levels or therapeutic monitoring of salicylate-containing medications.

The Salicylates (K813431) is intended for in vitro use in clinical laboratories, supplied as a reagent kit for single-use applications. It is regulated under FDA 510(k) clearance (K813431) with product code DKJ, falling under the Class II device classification (regulation number 862.3830). No information regarding sterility, MRI safety, or reusable components is provided in the specifications.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813431 Date25 Mar 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Salicylates
510(k) Number
FDA Product Code
DKJ
Device Class
Class II
Regulation
21 CFR Part 862.3830
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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