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510(k) K863203

Device
Cholinesterase (btc) Reagent
Applicant
SIGMA DIAGNOSTICS, INC.
510(k) number
K863203
Product code
DIH
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-17
Date received
1986-08-19
Regulation
862.3240
Classification name
Colorimetry, Cholinesterase
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATHEW MADAPPALLY
Address
P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DIH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K103373SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722Beckman Coulter, Inc.2011-02-07
K061093CHOLINESTERASE GEN.2 TEST SYSTEMRoche Diagnostics Corp.2006-07-03
K051444SENTINEL CHOLINESTERASE LIQUIDSentinel Ch. Srl2005-06-20
K030045OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)Olympus America, Inc.2003-02-21
K023992WIENER LAB COLINESTERASA AAWiener Laboratories Saic2003-02-12
K013750ADVIA 1650 CHOLINESTERASE ASSAYBayer Diagnostics Corp.2002-01-18
K002792CARESIDE CHOLINESTERASECareside, Inc.2000-11-08
K001344ADVIA IMSBayer Corp.2000-06-26
K961656TEST-MATE CHE CHOLINESTERASE TEST SYSTEMEqm Research, Inc.1996-11-26
K943367IL TEST CHOLINESTERASEInstrumentation Laboratory CO1996-02-05
K955498CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05Diagnostic Chemicals , Ltd.1996-01-24
K914171IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASETech Intl. Co.1991-12-18
K913198KODAK EKTACHEM DT SLIDES (CHE)Eastman Kodak Company1991-08-26
K912148CHOLINESTERASE TEST KITCrestat Diagnostics, Inc.1991-08-12
K912217KODAK EKTACHEM CLINICAL CHEMISTRY SLIDESEastman Kodak Company1991-07-01