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
49–72 of 86
Cleared Sep 13, 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007
Amresco, Inc.
Chemistry · 15d
Cleared Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
K902229
Coulter Corp.
Chemistry · 26d
Cleared Feb 23, 1990
CARBON DIOXIDE REAGENT
K896812
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Feb 13, 1990
CO2 REAGENT (340 NM)
K896258
Sigma Chemical Co.
Chemistry · 106d
Cleared Feb 01, 1990
CARBON DIOXIDE REAGENT
K896590
Pointe Scientific, Inc.,
Chemistry · 72d
Cleared Dec 21, 1989
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748
Catachem, Inc.
Chemistry · 86d
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 01, 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 245d
Cleared Aug 30, 1988
DART CARBON DIOXIDE
K883055
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Aug 02, 1988
ENZYMATIC CO2 REAGENT SET
K882497
American Monitor Corp.
Chemistry · 46d
Cleared Jun 15, 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938
Trace Scientific , Ltd.
Chemistry · 37d
Cleared Apr 28, 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 58d
Cleared Apr 28, 1988
CARBON DIOXIDE REAGENT
K881169
Intersect Systems, Inc.
Chemistry · 41d
Cleared Apr 18, 1988
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
K880794
Trace America, Inc.
Chemistry · 52d
Cleared Mar 16, 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609
Technicon Instruments Corp.
Chemistry · 33d
Cleared Mar 15, 1988
CO2 REAGENT
K880268
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Jan 05, 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941
Biotrol, USA, Inc.
Chemistry · 34d
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 Feb 13, 1987
BICARBONATE PROCEDURE
K870062
Data Medical Associates, Inc.
Chemistry · 37d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544
Em Diagnostic Systems, Inc.
Chemistry · 17d