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 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
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