Atlas FDA

KHS

86 FDA 510(k) clearances · Product code

58 daysmedian time to decision
212 days90th percentile
86clearances measured

FDA profile

Official device name
Enzymatic, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 31 · 2021: 14 · 2023: 25 · 2024: 30 · 2025: 41 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Carbon Dioxide Reagent Set (K170200)Teco Diagnostics, Inc.2017-06-01
Liquid CO2-2 (LCO2-2) (K152085)Randox Laboratories, Ltd.2016-02-24
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (K140248)Hitachi Chemical Diagnostics, Inc.2014-03-11
AU BICARBONATE REAGENT (K131546)Beckman Coulter Ireland, Inc.2013-10-09
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K123953)Alfa Wassermann Diagnostic Technologies, Inc.2013-05-02
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (K120765)Ortho-Clinical Diagnostics, Inc.2012-10-24
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K113435)Alfa Wassermann2012-07-02
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS (K111960)Elitechgroup2011-11-18
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 (K100060)Vital Diagnostics (Manufacturing) Ptyltd2010-12-15
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 (K100289)Siemens Healthcare Diagnostics2010-05-10
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; (K093611)Ortho-Clinical Diagnostics, Inc.2010-04-15
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 (K091153)Beckman Coulter, Inc.2009-07-13
S-TEST C02 (K073223)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-26
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (K071340)Thermofisher Scientific OY2007-10-05
CARBON DIOXIDE LIQUID STABLE REAGENT (K070251)Pointe Scientific, Inc.,2007-04-30
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A (K060619)Diazyme Laboratories2006-07-21
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE (K061238)Dade Behring, Inc.2006-05-25
CARBON DIOXIDE (K060295)Abbott Laboratories2006-05-04
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 (K042362)Diagnostic Chemicals , Ltd.2004-12-27
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID (K032377)Roche Diagnostics Corp.2003-08-21
COBAS INTEGRA CARBON DIOXIDE ASSAY (K031879)Roche Diagnostics Corp.2003-07-17
JAS CARBON DIOXIDE LIQUID REAGENT (K012332)Jas Diagnostics, Inc.2001-09-06
ANALYST PANELS + ANALYTICAL TEST ROTOR (K010864)Hemagen Diagnostics, Inc.2001-05-21
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 (K010206)Dade Behring, Inc.2001-03-16
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 (K002354)Diagnostic Chemicals , Ltd.2000-09-26
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 (K001133)Ortho-Clinical Diagnostics, Inc.2000-04-24
CARESIDE CO2, TOTAL (K992475)Careside, Inc.1999-09-15
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 (K991108)A.P. Total Care, Inc.1999-05-25
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 (K990754)Diagnostic Chemicals , Ltd.1999-04-20
CARBON DIOXIDE-SL ASSAY, CAT # 253-01 (K983019)Diagnostic Chemicals , Ltd.1998-09-14
RAICHEM CO2 REAGENT (K982056)Reagents Applications, Inc.1998-06-24
CO2 (K981840)Abbott Laboratories1998-06-08
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) (K980996)Roche Diagnostic Systems, Inc.1998-06-05
CO2 (K981231)Abbott Mfg., Inc.1998-05-12
CARBON DIOXIDE - DST (K960035)Trace America, Inc.1996-04-08
SYNERMED ENZYMATIC CO2 REAGENT KIT (K960793)Synermed, Inc.1996-03-11
SERUM BICARBONATE/CARBON DIOXIDE (K955302)Data Medical Associates, Inc.1996-02-29
TOTAL CO2 (K951221)Randox Laboratories, Ltd.1996-02-15
CARBON DIOXIDE - DST (K952410)Trace America, Inc.1995-10-05
CARBON DIOXIDE (C02) (K942735)Teco Diagnostics1995-03-20
BOEHRINGER MANNHEIM BICARBONATE ASSAY (K933461)Boehringer Mannheim Corp.1994-12-05
TECHNISON AXON SYSTEM (K941156)Miles, Inc.1994-04-26
ENZYMATIC CO2 REAGENT, MODIFICATION (K932267)Intersect Systems, Inc.1993-09-24
BICARBONATE (K931887)Em Diagnostic Systems, Inc.1993-08-03
SYNERMED ENZYMATIC CO2 REAGENT KIT (K924428)Synermed, Inc.1992-12-03
BICARBONATE (K924711)Em Diagnostic Systems, Inc.1992-12-03
COULTER CARBON DIOXIDE REAGENT (K914486)Coulter Corp.1991-11-27
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 (K912806)Em Diagnostic Systems, Inc.1991-09-11
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE (K903409)Em Diagnostic Systems, Inc.1990-10-04
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (K903305)Technicon Instruments Corp.1990-09-27
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2) (K903144)Eastman Kodak Company1990-09-25
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 (K904007)Amresco, Inc.1990-09-13
COULTER CARBON DIOXIDE REAGENT (K902229)Coulter Corp.1990-06-12
CARBON DIOXIDE REAGENT (K896812)Pointe Scientific, Inc.,1990-02-23
CO2 REAGENT (340 NM) (K896258)Sigma Chemical Co.1990-02-13
CARBON DIOXIDE REAGENT (K896590)Pointe Scientific, Inc.,1990-02-01
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (K895748)Catachem, Inc.1989-12-21
BICARBONATE TEST ITEM NUMBER: 65412 (K894509)Em Diagnostic Systems, Inc.1989-09-15
BICARBONATE; SYSTEM PACK REAGENTS (K891991)Boehringer Mannheim Corp.1989-06-09
BICARBONATE TEST ITEM NUMBER: SR1006 (K890305)Em Diagnostic Systems, Inc.1989-02-17
ABBOTT SPECTRUM(R) BICARBONATE REAGENT (K884821)Abbott Laboratories1988-12-27
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 (K880868)Diagnostic Chemicals, Ltd. (Usa)1988-11-01
DART CARBON DIOXIDE (K883055)Coulter Electronics, Inc.1988-08-30
ENZYMATIC CO2 REAGENT SET (K882497)American Monitor Corp.1988-08-02
BICARBONATE (CO2) REAGENT-2 VIAL (K881938)Trace Scientific , Ltd.1988-06-15
CARBON DIOXIDE REAGENT (K881169)Intersect Systems, Inc.1988-04-28
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 (K880866)Diagnostic Chemicals, Ltd. (Usa)1988-04-28
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL (K880794)Trace America, Inc.1988-04-18
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) (K880609)Technicon Instruments Corp.1988-03-16
CO2 REAGENT (K880268)Sigma Diagnostics, Inc.1988-03-15
BIOTROL BICARBONATE (CO2) UV HP) (K874941)Biotrol, USA, Inc.1988-01-05
BICARBONATE (K874435)Boehringer Mannheim Corp.1987-11-23
ABBOTT SPECTRUM BICARBONATE REAGENT KIT (K872108)Abbott Laboratories1987-06-17
BICARBONATE PROCEDURE (K870062)Data Medical Associates, Inc.1987-02-13
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 (K863544)Em Diagnostic Systems, Inc.1986-09-29
BICARBONATE PROCEDURE (K861673)Data Medical Associates, Inc.1986-07-01
RAICHEM CO2 REAGENT (K854544)Reagents Applications, Inc.1985-12-13
DATA ZYME CO2 PROCEDURE (K850903)Data Medical Associates, Inc.1985-04-08
ROCHE REAGENTS REAGENT FOR CO2 (K844987)Roche Diagnostic Systems, Inc.1985-01-18
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL (K841664)Diagnostic Chemicals, Ltd. (Usa)1984-06-08
DEMAND C02 (K841726)Cooper Biomedical, Inc.1984-06-07
CARBON DIOXIDE REAGENT (K840773)American Dade1984-04-04
ENZYMATIC CO2 (K822079)American Monitor Corp.1982-07-27
BICARBONATE TEST (K810356)Boehringer Mannheim Corp.1981-02-23
MULTISTAT III BICARBONATE TEST (K771507)Instrumentation Laboratory CO1977-10-25
REAGENT KIT, ENZYMATIC CO2 (K760546)Beckman Instruments, Inc.1976-11-01

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