FDA 510(k) Applications for Medical Device Product Code "KHS"
(Enzymatic, Carbon-Dioxide)

FDA 510(k) Number Applicant Device Name Decision Date
K991108 A.P. TOTAL CARE, INC. CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 05/25/1999
K060295 ABBOTT LABORATORIES CARBON DIOXIDE 05/04/2006
K981840 ABBOTT LABORATORIES CO2 06/08/1998
K981231 ABBOTT MFG., INC. CO2 05/12/1998
K113435 ALFA WASSERMANN ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT 07/02/2012
K123953 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT 05/02/2013
K073223 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S-TEST C02 06/26/2008
K131546 BECKMAN COULTER IRELAND INC AU BICARBONATE REAGENT 10/09/2013
K091153 BECKMAN COULTER, INC. SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 07/13/2009
K992475 CARESIDE, INC. CARESIDE CO2, TOTAL 09/15/1999
K010206 DADE BEHRING, INC. DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 03/16/2001
K061238 DADE BEHRING, INC. DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE 05/25/2006
K955302 DATA MEDICAL ASSOCIATES, INC. SERUM BICARBONATE/CARBON DIOXIDE 02/29/1996
K990754 DIAGNOSTIC CHEMICALS LTD. CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 04/20/1999
K002354 DIAGNOSTIC CHEMICALS LTD. CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 09/26/2000
K983019 DIAGNOSTIC CHEMICALS LTD. CARBON DIOXIDE-SL ASSAY, CAT # 253-01 09/14/1998
K042362 DIAGNOSTIC CHEMICALS LTD. MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 12/27/2004
K060619 DIAZYME LABORATORIES DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A 07/21/2006
K111960 ELITECHGROUP ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS 11/18/2011
K010864 HEMAGEN DIAGNOSTICS, INC. ANALYST PANELS + ANALYTICAL TEST ROTOR 05/21/2001
K140248 HITACHI CHEMICAL DIAGNOSTICS, INC. S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) 03/11/2014
K012332 JAS Diagnostics, Inc. JAS CARBON DIOXIDE LIQUID REAGENT 09/06/2001
K001133 Ortho-Clinical Diagnostics, Inc. VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 04/24/2000
K093611 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; 04/15/2010
K120765 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS ECO2 SLIDES 10/24/2012
K070251 POINTE SCIENTIFIC, INC. CARBON DIOXIDE LIQUID STABLE REAGENT 04/30/2007
K152085 RANDOX LABORATORIES LTD Liquid CO2-2 (LCO2-2) 02/24/2016
K951221 RANDOX LABORATORIES, LTD. TOTAL CO2 02/15/1996
K982056 REAGENTS APPLICATIONS, INC. RAICHEM CO2 REAGENT 06/24/1998
K980996 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) 06/05/1998
K031879 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA CARBON DIOXIDE ASSAY 07/17/2003
K032377 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID 08/21/2003
K100289 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 05/10/2010
K960793 SYNERMED, INC. SYNERMED ENZYMATIC CO2 REAGENT KIT 03/11/1996
K170200 Teco Diagnostics, Inc. Carbon Dioxide Reagent Set 06/01/2017
K071340 THERMO FISHER SCIENTIFIC OY CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL 10/05/2007
K960035 TRACE AMERICA, INC. CARBON DIOXIDE - DST 04/08/1996
K100060 VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 12/15/2010


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact