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KHS — Enzymatic, Carbon-Dioxide Class II

FDA Device Classification

Classification Details

Product Code
KHS
Device Class
Class II
Regulation Number
862.1160
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170200teco diagnosticsCarbon Dioxide Reagent SetJune 1, 2017
K152085randox laboratoriesLiquid CO2-2 (LCO2-2)February 24, 2016
K140248hitachi chemical diagnosticsS TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)March 11, 2014
K131546beckman coulter irelandAU BICARBONATE REAGENTOctober 9, 2013
K123953alfa wassermann diagnostic technologiesACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAMay 2, 2013
K120765ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS ECO2 SLIDESOctober 24, 2012
K113435alfa wassermannACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIJuly 2, 2012
K111960elitechgroupELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE November 18, 2011
K100060vital diagnostics (manufacturing) ptyltdEON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77December 15, 2010
K100289siemens healthcare diagnosticsADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100,May 10, 2010
K093611ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOApril 15, 2010
K091153beckman coulterSYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291July 13, 2009
K073223alfa wassermann diagnostic technologiesS-TEST C02June 26, 2008
K071340thermofisher scientificCARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROLOctober 5, 2007
K070251pointe scientific, incCARBON DIOXIDE LIQUID STABLE REAGENTApril 30, 2007
K060619diazyme laboratoriesDIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122AJuly 21, 2006
K061238dade behringDIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENMay 25, 2006
K060295abbott laboratoriesCARBON DIOXIDEMay 4, 2006
K042362diagnostic chemicalsMODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-December 27, 2004
K032377roche diagnosticsROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUIDAugust 21, 2003