Product Code: DIH FDA class 1 21 CFR 862.3240

Colorimetry, Cholinesterase

Clinical Toxicology

The Colorimetric Cholinesterase test is a laboratory reagent system used to measure cholinesterase enzyme activity in blood or plasma through colorimetric methods, helping to identify toxic exposure to organophosphate compounds or to diagnose conditions causing cholinesterase deficiency. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification. The device is regulated under 21 CFR 862.3240 within the Clinical Toxicology specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: DIH
Device Class: FDA class 1
Regulation Number: 862.3240
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K103373	SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722	Feb 07, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K061093	CHOLINESTERASE GEN.2 TEST SYSTEM	Jul 03, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K051444	SENTINEL CHOLINESTERASE LIQUID	Jun 20, 2005	Substantially Equivalent	Sentinel Ch. Srl
K030045	OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)	Feb 21, 2003	Substantially Equivalent	Olympus America, Inc.
K023992	WIENER LAB COLINESTERASA AA	Feb 12, 2003	Substantially Equivalent	Wiener Laboratories Saic
K013750	ADVIA 1650 CHOLINESTERASE ASSAY	Jan 18, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K002792	CARESIDE CHOLINESTERASE	Nov 08, 2000	Substantially Equivalent	Careside, Inc.
K001344	ADVIA IMS	Jun 26, 2000	Substantially Equivalent	Bayer Corp.
K961656	TEST-MATE CHE CHOLINESTERASE TEST SYSTEM	Nov 26, 1996	Substantially Equivalent	Eqm Research, Inc.
K943367	IL TEST CHOLINESTERASE	Feb 05, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K955498	CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05	Jan 24, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K914171	IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE	Dec 18, 1991	Substantially Equivalent	Tech Intl. Co.
K913198	KODAK EKTACHEM DT SLIDES (CHE)	Aug 26, 1991	Substantially Equivalent	Eastman Kodak Company
K912148	CHOLINESTERASE TEST KIT	Aug 12, 1991	Substantially Equivalent	Crestat Diagnostics, Inc.
K912217	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES	Jul 01, 1991	Substantially Equivalent	Eastman Kodak Company
K893583	BECKMAN CHOLINESTERASE REAGENT KIT	Aug 15, 1989	Substantially Equivalent	Beckman
K885272	CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE	Mar 28, 1989	Substantially Equivalent	Sigma Chemical Co.
K880199	CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE	Jan 27, 1989	Substantially Equivalent	Sclavo, Inc.
K880049	CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE	Jan 27, 1989	Substantially Equivalent	Sclavo, Inc.
K873496	ATYPICAL CHOLINESTERASE	Jan 27, 1989	Substantially Equivalent	Sclavo, Inc.
K883890	DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD	Nov 29, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K863203	CHOLINESTERASE (BTC) REAGENT	Sep 17, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K863202	CHOLINESTERASE (PTC) REAGENT	Sep 16, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K863111	CHOLINESTERASE	Sep 11, 1986	Substantially Equivalent	J. D. Assoc.
K862168	RAICHEM CHOLINESTERASE REAGENT	Jun 27, 1986	Substantially Equivalent	Reagents Applications, Inc.
K791725	CHOLINESTERASE REAGENT	Oct 17, 1979	Substantially Equivalent	Gilford Diagnostics