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 |