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
86 devices
25–48 of 86
Cleared Sep 15, 1999
CARESIDE CO2, TOTAL
K992475
Careside, Inc.
Chemistry · 51d
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108
A.P. Total Care, Inc.
Chemistry · 54d
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 May 12, 1998
CO2
K981231
Abbott Mfg., Inc.
Chemistry · 39d
Cleared Apr 08, 1996
CARBON DIOXIDE - DST
K960035
Trace America, Inc.
Chemistry · 96d
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
Cleared Oct 05, 1995
CARBON DIOXIDE - DST
K952410
Trace America, Inc.
Chemistry · 134d
Cleared Mar 20, 1995
CARBON DIOXIDE (C02)
K942735
Teco Diagnostics
Chemistry · 283d
Cleared Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461
Boehringer Mannheim Corp.
Chemistry · 507d
Cleared Sep 24, 1993
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267
Intersect Systems, Inc.
Chemistry · 163d
Cleared Aug 03, 1993
BICARBONATE
K931887
Em Diagnostic Systems, Inc.
Chemistry · 110d
Cleared Dec 03, 1992
SYNERMED ENZYMATIC CO2 REAGENT KIT
K924428
Synermed, Inc.
Chemistry · 93d
Cleared Dec 03, 1992
BICARBONATE
K924711
Em Diagnostic Systems, Inc.
Hematology · 76d
Cleared Nov 27, 1991
COULTER CARBON DIOXIDE REAGENT
K914486
Coulter Corp.
Chemistry · 50d
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 27, 1990
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
K903305
Technicon Instruments Corp.
Chemistry · 65d
Cleared Sep 25, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
K903144
Eastman Kodak Company
Chemistry · 69d