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 Abbott Laboratories.

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 Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153
Beckman Coulter, Inc.
Chemistry · 83d
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 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 Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206
Dade Behring, Inc.
Chemistry · 52d
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 Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461
Boehringer Mannheim Corp.
Chemistry · 507d
Cleared Aug 03, 1993
BICARBONATE
K931887
Em Diagnostic Systems, Inc.
Chemistry · 110d
Cleared Dec 03, 1992
BICARBONATE
K924711
Em Diagnostic Systems, Inc.
Hematology · 76d
Cleared Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Sep 25, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
K903144
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 13, 1990
CO2 REAGENT (340 NM)
K896258
Sigma Chemical Co.
Chemistry · 106d
Cleared Sep 15, 1989
BICARBONATE TEST ITEM NUMBER: 65412
K894509
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Jun 09, 1989
BICARBONATE
K891991
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Feb 17, 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305
Em Diagnostic Systems, Inc.
Chemistry · 25d
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821
Abbott Laboratories
Chemistry · 40d
Cleared Nov 23, 1987
BICARBONATE
K874435
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Jun 17, 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108
Abbott Laboratories
Chemistry · 16d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Feb 23, 1981
BICARBONATE TEST
K810356
Boehringer Mannheim Corp.
Chemistry · 13d

About Product Code KHS - Regulatory Context