KHS · Class II · 21 CFR 862.1160

FDA Product Code KHS: Enzymatic, Carbon-dioxide

Leading manufacturers include Em Diagnostic Systems, Inc., Diagnostic Chemicals , Ltd. and Boehringer Mannheim Corp..

86
Total
86
Cleared
86d
Avg days
1976
Since

FDA 510(k) Cleared Enzymatic, Carbon-dioxide Devices (Product Code KHS)

86 devices
1–24 of 86
Cleared Jun 01, 2017
Carbon Dioxide Reagent Set
K170200
Teco Diagnostics, Inc.
Chemistry · 129d
Cleared Feb 24, 2016
Liquid CO2-2 (LCO2-2)
K152085
Randox Laboratories, Ltd.
Chemistry · 212d
Cleared Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248
Hitachi Chemical Diagnostics, Inc.
Chemistry · 40d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546
Beckman Coulter Ireland, Inc.
Chemistry · 133d
Cleared May 02, 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 132d
Cleared Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765
Ortho-Clinical Diagnostics, Inc.
Chemistry · 225d
Cleared Jul 02, 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K113435
Alfa Wassermann
Chemistry · 224d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
K111960
Elitechgroup
Chemistry · 130d
Cleared May 10, 2010
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
K100289
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared Apr 15, 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
K093611
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153
Beckman Coulter, Inc.
Chemistry · 83d
Cleared Jun 26, 2008
S-TEST C02
K073223
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 224d
Cleared Apr 30, 2007
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251
Pointe Scientific, Inc.,
Chemistry · 94d
Cleared Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619
Diazyme Laboratories
Chemistry · 135d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238
Dade Behring, Inc.
Chemistry · 22d
Cleared May 04, 2006
CARBON DIOXIDE
K060295
Abbott Laboratories
Chemistry · 87d
Cleared Dec 27, 2004
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362
Diagnostic Chemicals , Ltd.
Chemistry · 118d
Cleared Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332
Jas Diagnostics, Inc.
Chemistry · 45d
Cleared May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864
Hemagen Diagnostics, Inc.
Chemistry · 60d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206
Dade Behring, Inc.
Chemistry · 52d
Cleared Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354
Diagnostic Chemicals , Ltd.
Toxicology · 55d
Cleared Apr 24, 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d

About Product Code KHS - Regulatory Context