Product Code: DKJ FDA class 2 21 CFR 862.3830

Colorimetry, Salicylate

Clinical Toxicology

The Colorimetric Salicylate test uses colorimetric chemical reactions to detect and quantify salicylate compounds, including aspirin and its metabolites, in patient specimens, supporting therapeutic drug monitoring and toxicology evaluations for salicylate overdose. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3830 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DKJ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DKJ
Device Class: FDA class 2
Regulation Number: 862.3830
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K093939	ADVIA CHEMISTRY SALICYLATE REAGENT	May 19, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K042329	SALICYLATE-SL ASSAY	Dec 27, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K020794	SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Jul 11, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K014173	SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR	Feb 15, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K011878	EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL	Aug 13, 2001	Substantially Equivalent	Syva Co.
K981872	SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40	Jun 29, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K980032	SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71	Mar 02, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K964715	PARAMAX SALICYLATE REAGENT	Apr 25, 1997	Substantially Equivalent	Dade Intl., Inc.
K961131	SALICYLATE ASSAY	Apr 29, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K951290	AXSYM SALICYLATE	Aug 08, 1995	Substantially Equivalent	Abbott Laboratories
K946000	ABUSCREEN ONLINE(R) CALIBRATORS	Jan 25, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904301	DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD	Nov 09, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K902356	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)	Jul 16, 1990	Substantially Equivalent	Eastman Kodak Company
K882038	GDS ENZYMATIC SALICYLATE REAGENT	Jun 24, 1988	Substantially Equivalent	Gds Technology, LLC
K873425	EASY-TEST SALICYLATE (SAL) #16691	Oct 29, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K872321	EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93	Aug 28, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K872330	EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95	Jul 09, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870336	SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71	Feb 20, 1987	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K861615	SALICYLATE REAGENT SET	May 23, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K852027	GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER	May 29, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K844070	TDX SALICYLATE	Nov 27, 1984	Substantially Equivalent	Abbott Laboratories
K842158	SALICYLATE ASSAY KIT	Oct 22, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K843180	SALICYLATE TEST	Sep 07, 1984	Substantially Equivalent	Sclavo, Inc.
K840243	DETERMIN. OF SALICYLATE IN SERUM/PLAST	Mar 23, 1984	Substantially Equivalent	Sigma Chemical Co.
K833003	PARAMAX SALICYLATE REAGENT	Oct 28, 1983	Substantially Equivalent	American Dade
K831336	SALICYLATE ASSAY KIT	Jul 07, 1983	Substantially Equivalent	Quantimetrix Corp.
K823523	TOXI-LAB RAPID SCREEN	Jan 14, 1983	Substantially Equivalent	Marion Laboratories, Inc.
K813431	SALICYLATES	Mar 25, 1982	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K813185	SALICYLATE STAT-PAK	Nov 24, 1981	Substantially Equivalent	Clin Tech Diagnostics Corp.