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DIH — Colorimetry, Cholinesterase Class I

FDA Device Classification

Classification Details

Product Code
DIH
Device Class
Class I
Regulation Number
862.3240
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K103373beckman coulterSYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722February 7, 2011
K061093roche diagnosticsCHOLINESTERASE GEN.2 TEST SYSTEMJuly 3, 2006
K051444sentinel chSENTINEL CHOLINESTERASE LIQUIDJune 20, 2005
K030045olympus americaOLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)February 21, 2003
K023992wiener laboratories saicWIENER LAB COLINESTERASA AAFebruary 12, 2003
K013750bayer diagnosticsADVIA 1650 CHOLINESTERASE ASSAYJanuary 18, 2002
K002792caresideCARESIDE CHOLINESTERASENovember 8, 2000
K001344bayerADVIA IMSJune 26, 2000
K961656eqm researchTEST-MATE CHE CHOLINESTERASE TEST SYSTEMNovember 26, 1996
K943367instrumentation laboratoryIL TEST CHOLINESTERASEFebruary 5, 1996
K955498diagnostic chemicalsCHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05January 24, 1996
K914171tech intlIN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASEDecember 18, 1991
K913198eastman kodakKODAK EKTACHEM DT SLIDES (CHE)August 26, 1991
K912148crestat diagnosticsCHOLINESTERASE TEST KITAugust 12, 1991
K912217eastman kodakKODAK EKTACHEM CLINICAL CHEMISTRY SLIDESJuly 1, 1991
K893583beckmanBECKMAN CHOLINESTERASE REAGENT KITAugust 15, 1989
K885272sigma chemicalCHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDEMarch 28, 1989
K880199sclavoCHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATEJanuary 27, 1989
K880049sclavoCHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATEJanuary 27, 1989
K873496sclavoATYPICAL CHOLINESTERASEJanuary 27, 1989