KHS · Class II · 21 CFR 862.1160

FDA Product Code KHS: Enzymatic, Carbon-dioxide

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

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 Feb 24, 2016
Liquid CO2-2 (LCO2-2)
K152085
Randox Laboratories, Ltd.
Chemistry · 212d
Cleared Oct 24, 2012
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765
Ortho-Clinical Diagnostics, Inc.
Chemistry · 225d
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 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 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
Cleared Apr 20, 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754
Diagnostic Chemicals , Ltd.
Chemistry · 43d
Cleared Sep 14, 1998
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Jun 24, 1998
RAICHEM CO2 REAGENT
K982056
Reagents Applications, Inc.
Chemistry · 15d
Cleared Jun 08, 1998
CO2
K981840
Abbott Laboratories
Chemistry · 13d
Cleared Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 11, 1996
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793
Synermed, Inc.
Chemistry · 13d
Cleared Feb 29, 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302
Data Medical Associates, Inc.
Chemistry · 101d
Cleared Feb 15, 1996
TOTAL CO2
K951221
Randox Laboratories, Ltd.
Chemistry · 332d

About Product Code KHS - Regulatory Context