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510(k) K981840

Device
Co2
Applicant
ABBOTT LABORATORIES
510(k) number
K981840
Product code
KHS
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-08
Date received
1998-05-26
Regulation
862.1160
Classification name
Enzymatic, Carbon-Dioxide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARK LITTLEFIELD
Address
1920 Hurd Dr. Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.2017-06-01
K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.2016-02-24
K140248S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)Hitachi Chemical Diagnostics, Inc.2014-03-11
K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.2013-10-09
K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2013-05-02
K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.2012-10-24
K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann2012-07-02
K111960ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORSElitechgroup2011-11-18
K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475Vital Diagnostics (Manufacturing) Ptyltd2010-12-15
K100289ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781Siemens Healthcare Diagnostics2010-05-10
K093611VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;Ortho-Clinical Diagnostics, Inc.2010-04-15
K091153SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291Beckman Coulter, Inc.2009-07-13
K073223S-TEST C02Alfa Wassermann Diagnostic Technologies, Inc.2008-06-26
K071340CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROLThermofisher Scientific OY2007-10-05
K070251CARBON DIOXIDE LIQUID STABLE REAGENTPointe Scientific, Inc.,2007-04-30