Product code KHS

Device name: Enzymatic, Carbon-Dioxide
Medical specialty: Clinical Chemistry
Device class: 2
Regulation number: 862.1160
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K170200	Carbon Dioxide Reagent Set	Teco Diagnostics, Inc.	2017-06-01
K152085	Liquid CO2-2 (LCO2-2)	Randox Laboratories, Ltd.	2016-02-24
K140248	S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)	Hitachi Chemical Diagnostics, Inc.	2014-03-11
K131546	AU BICARBONATE REAGENT	Beckman Coulter Ireland, Inc.	2013-10-09
K123953	ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT	Alfa Wassermann Diagnostic Technologies, Inc.	2013-05-02
K120765	VITROS CHEMISTRY PRODUCTS ECO2 SLIDES	Ortho-Clinical Diagnostics, Inc.	2012-10-24
K113435	ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT	Alfa Wassermann	2012-07-02
K111960	ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS	Elitechgroup	2011-11-18
K100060	EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475	Vital Diagnostics (Manufacturing) Ptyltd	2010-12-15
K100289	ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781	Siemens Healthcare Diagnostics	2010-05-10
K093611	VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;	Ortho-Clinical Diagnostics, Inc.	2010-04-15
K091153	SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291	Beckman Coulter, Inc.	2009-07-13
K073223	S-TEST C02	Alfa Wassermann Diagnostic Technologies, Inc.	2008-06-26
K071340	CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL	Thermofisher Scientific OY	2007-10-05
K070251	CARBON DIOXIDE LIQUID STABLE REAGENT	Pointe Scientific, Inc.,	2007-04-30
K060619	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A	Diazyme Laboratories	2006-07-21
K061238	DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2006-05-25
K060295	CARBON DIOXIDE	Abbott Laboratories	2006-05-04
K042362	MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12	Diagnostic Chemicals , Ltd.	2004-12-27
K032377	ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID	Roche Diagnostics Corp.	2003-08-21
K031879	COBAS INTEGRA CARBON DIOXIDE ASSAY	Roche Diagnostics Corp.	2003-07-17
K012332	JAS CARBON DIOXIDE LIQUID REAGENT	Jas Diagnostics, Inc.	2001-09-06
K010864	ANALYST PANELS + ANALYTICAL TEST ROTOR	Hemagen Diagnostics, Inc.	2001-05-21
K010206	DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137	Dade Behring, Inc.	2001-03-16
K002354	CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80	Diagnostic Chemicals , Ltd.	2000-09-26
K001133	VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2	Ortho-Clinical Diagnostics, Inc.	2000-04-24
K992475	CARESIDE CO2, TOTAL	Careside, Inc.	1999-09-15
K991108	CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01	A.P. Total Care, Inc.	1999-05-25
K990754	CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50	Diagnostic Chemicals , Ltd.	1999-04-20
K983019	CARBON DIOXIDE-SL ASSAY, CAT # 253-01	Diagnostic Chemicals , Ltd.	1998-09-14

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00817089023048	Diazyme	DIAZYME LABORATORIES, INC.	2026-01-21
10673486001624	Teco Diagnostics Carbon Dioxide (CO2) Reagent Set	TECO DIAGNOSTICS	2023-07-25
00811727016102	Pointe Carbon Dioxide Reagent	HORIBA INSTRUMENTS INCORPORATED	2021-01-30
03610230006863	Yumizen C1200 CO2	HORIBA ABX SAS	2020-08-28
00811727015792	Pointe Carbon Dioxide on the BS480	HORIBA INSTRUMENTS INCORPORATED	2020-05-28
07613336121146	Bicarbonate Liquid	Roche Diagnostics GmbH	2020-03-05
00380740161545	ARCHITECT	Abbott GmbH	2020-01-25
00380740161538	ARCHITECT	Abbott GmbH	2020-01-04
00380740161521	ARCHITECT	Abbott GmbH	2020-01-04
00386100002053	CO2 Reagent Kit	MEDICA CORPORATION	2019-02-14
00817089020054	Diazyme	DIAZYME LABORATORIES, INC.	2016-11-03
00817089020047	Diazyme	DIAZYME LABORATORIES, INC.	2016-11-03
00817302022988	CAROLINA LIQUID CHEMISTRIES CORP.® CO2 REAGENT PRODUCT NO. DT313	CAROLINA LIQUID CHEMISTRIES CORPORATION	2016-10-17
EABA40000341	Piccolo MetLyte Plus CRP	ABAXIS, INC.	2016-09-23
EABA40000371	Piccolo MetLac 12 Panel	ABAXIS, INC.	2016-09-23
EABA40000281	Piccolo Comprehensive Metabolic Panel	ABAXIS, INC.	2016-09-23
EABA40000271	Piccolo Renal Function Panel	ABAXIS, INC.	2016-09-23
EABA40000241	Piccolo Basic Metabolic Panel	ABAXIS, INC.	2016-09-23
EABA40000231	Piccolo MetLyte 8 Panel	ABAXIS, INC.	2016-09-23
EABA40000221	Piccolo Electrolyte Panel	ABAXIS, INC.	2016-09-23
EABA40000311	Piccolo Basic Metabolic Panel Plus	ABAXIS, INC.	2016-09-23
04015630919352	Bicarbonate liquid	Roche Diagnostics GmbH	2016-09-20
04015630997237	Bircarbonate liquid	Roche Diagnostics GmbH	2016-09-20
04015630935673	BicarbonateBicarbonate STAT	Roche Diagnostics GmbH	2016-09-20
04015630927395	Bircarbonate liquid	Roche Diagnostics GmbH	2016-09-20
04015630919376	Bicarbonate liquid	Roche Diagnostics GmbH	2016-09-20
04015630919369	Bicarbonate liquid	Roche Diagnostics GmbH	2016-09-20
00817302022025	CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313	CAROLINA LIQUID CHEMISTRIES CORPORATION	2016-09-01
10758750004645	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-26
03610230005071	ABX PENTRA CO2 RTU	HORIBA ABX SAS	2016-08-23

Product code KHS

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