FDA Product Code
FDA Product Code KHS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1160
510(k) Clearances — 86 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | 2017-06-01 | Traditional | PDF ↗ |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | 2016-02-24 | Traditional | PDF ↗ |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014-03-11 | Traditional | PDF ↗ |
| K131546 | AU BICARBONATE REAGENT | Beckman Coulter Ireland, Inc. | 2013-10-09 | Traditional | PDF ↗ |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 | Special | PDF ↗ |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann | 2012-07-02 | Traditional | PDF ↗ |
| K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | Elitechgroup | 2011-11-18 | Traditional | PDF ↗ |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | Vital Diagnostics (Manufacturing) Ptyltd | 2010-12-15 | Traditional | PDF ↗ |
| K100289 | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 | Siemens Healthcare Diagnostics | 2010-05-10 | Traditional | PDF ↗ |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; | Ortho-Clinical Diagnostics, Inc. | 2010-04-15 | Traditional | PDF ↗ |
| K091153 | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | Beckman Coulter, Inc. | 2009-07-13 | Traditional | PDF ↗ |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 | Traditional | PDF ↗ |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-05 | Traditional | PDF ↗ |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | 2007-04-30 | Traditional | PDF ↗ |
| K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | Diazyme Laboratories | 2006-07-21 | Traditional | PDF ↗ |
| K061238 | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-05-25 | Special | PDF ↗ |
| K060295 | CARBON DIOXIDE | Abbott Laboratories | 2006-05-04 | Traditional | PDF ↗ |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | Diagnostic Chemicals , Ltd. | 2004-12-27 | Traditional | PDF ↗ |
| K032377 | ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID | Roche Diagnostics Corp. | 2003-08-21 | Special | PDF ↗ |
| K031879 | COBAS INTEGRA CARBON DIOXIDE ASSAY | Roche Diagnostics Corp. | 2003-07-17 | Special | PDF ↗ |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-09-06 | Traditional | PDF ↗ |
| K010864 | ANALYST PANELS + ANALYTICAL TEST ROTOR | Hemagen Diagnostics, Inc. | 2001-05-21 | Traditional | PDF ↗ |
| K010206 | DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 | Dade Behring, Inc. | 2001-03-16 | Traditional | PDF ↗ |
| K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 | Diagnostic Chemicals , Ltd. | 2000-09-26 | Traditional | PDF ↗ |
| K001133 | VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2000-04-24 | Special | PDF ↗ |
| K992475 | CARESIDE CO2, TOTAL | Careside, Inc. | 1999-09-15 | Traditional | PDF ↗ |
| K991108 | CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K990754 | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 | Diagnostic Chemicals , Ltd. | 1999-04-20 | Traditional | PDF ↗ |
| K983019 | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 | Diagnostic Chemicals , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982056 | RAICHEM CO2 REAGENT | Reagents Applications, Inc. | 1998-06-24 | Special | PDF ↗ |
| K981840 | CO2 | Abbott Laboratories | 1998-06-08 | Traditional | PDF ↗ |
| K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) | Roche Diagnostic Systems, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K981231 | CO2 | Abbott Mfg., Inc. | 1998-05-12 | Traditional | PDF ↗ |
| K960035 | CARBON DIOXIDE - DST | Trace America, Inc. | 1996-04-08 | Traditional | PDF ↗ |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Synermed, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Data Medical Associates, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K951221 | TOTAL CO2 | Randox Laboratories, Ltd. | 1996-02-15 | Traditional | PDF ↗ |
| K952410 | CARBON DIOXIDE - DST | Trace America, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K942735 | CARBON DIOXIDE (C02) | Teco Diagnostics | 1995-03-20 | Traditional | PDF ↗ |
| K933461 | BOEHRINGER MANNHEIM BICARBONATE ASSAY | Boehringer Mannheim Corp. | 1994-12-05 | Traditional | PDF ↗ |
| K941156 | TECHNISON AXON SYSTEM | Miles, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | Intersect Systems, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K931887 | BICARBONATE | Em Diagnostic Systems, Inc. | 1993-08-03 | Traditional | PDF ↗ |
| K924428 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Synermed, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K924711 | BICARBONATE | Em Diagnostic Systems, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K914486 | COULTER CARBON DIOXIDE REAGENT | Coulter Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K912806 | ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 | Em Diagnostic Systems, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K903409 | SYSTEMATE BICARBONATE OLYMPUS BICARBONATE | Em Diagnostic Systems, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Technicon Instruments Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K903144 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2) | Eastman Kodak Company | 1990-09-25 | Traditional | PDF ↗ |
| K904007 | BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 | Amresco, Inc. | 1990-09-13 | Traditional | PDF ↗ |
| K902229 | COULTER CARBON DIOXIDE REAGENT | Coulter Corp. | 1990-06-12 | Traditional | PDF ↗ |
| K896812 | CARBON DIOXIDE REAGENT | Pointe Scientific, Inc., | 1990-02-23 | Traditional | PDF ↗ |
| K896258 | CO2 REAGENT (340 NM) | Sigma Chemical Co. | 1990-02-13 | Traditional | PDF ↗ |
| K896590 | CARBON DIOXIDE REAGENT | Pointe Scientific, Inc., | 1990-02-01 | Traditional | PDF ↗ |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K894509 | BICARBONATE TEST ITEM NUMBER: 65412 | Em Diagnostic Systems, Inc. | 1989-09-15 | Traditional | PDF ↗ |
| K891991 | BICARBONATE; SYSTEM PACK REAGENTS | Boehringer Mannheim Corp. | 1989-06-09 | Traditional | PDF ↗ |
| K890305 | BICARBONATE TEST ITEM NUMBER: SR1006 | Em Diagnostic Systems, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K884821 | ABBOTT SPECTRUM(R) BICARBONATE REAGENT | Abbott Laboratories | 1988-12-27 | Traditional | PDF ↗ |
| K880868 | CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 | Diagnostic Chemicals, Ltd. (Usa) | 1988-11-01 | Traditional | PDF ↗ |
| K883055 | DART CARBON DIOXIDE | Coulter Electronics, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K882497 | ENZYMATIC CO2 REAGENT SET | American Monitor Corp. | 1988-08-02 | Traditional | PDF ↗ |
| K881938 | BICARBONATE (CO2) REAGENT-2 VIAL | Trace Scientific , Ltd. | 1988-06-15 | Traditional | PDF ↗ |
| K880866 | CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-28 | Traditional | PDF ↗ |
| K881169 | CARBON DIOXIDE REAGENT | Intersect Systems, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880794 | RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL | Trace America, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880609 | ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) | Technicon Instruments Corp. | 1988-03-16 | Traditional | PDF ↗ |
| K880268 | CO2 REAGENT | Sigma Diagnostics, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K874941 | BIOTROL BICARBONATE (CO2) UV HP) | Biotrol, USA, Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K874435 | BICARBONATE | Boehringer Mannheim Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K872108 | ABBOTT SPECTRUM BICARBONATE REAGENT KIT | Abbott Laboratories | 1987-06-17 | Traditional | PDF ↗ |
| K870062 | BICARBONATE PROCEDURE | Data Medical Associates, Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K863544 | EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 | Em Diagnostic Systems, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K861673 | BICARBONATE PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K854544 | RAICHEM CO2 REAGENT | Reagents Applications, Inc. | 1985-12-13 | Traditional | PDF ↗ |
| K850903 | DATA ZYME CO2 PROCEDURE | Data Medical Associates, Inc. | 1985-04-08 | Traditional | PDF ↗ |
| K844987 | ROCHE REAGENTS REAGENT FOR CO2 | Roche Diagnostic Systems, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K841664 | ENZYMATIC CO2 DIAGNOSTIC CHEMICAL | Diagnostic Chemicals, Ltd. (Usa) | 1984-06-08 | Traditional | PDF ↗ |
| K841726 | DEMAND C02 | Cooper Biomedical, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K840773 | CARBON DIOXIDE REAGENT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K822079 | ENZYMATIC CO2 | American Monitor Corp. | 1982-07-27 | Traditional | PDF ↗ |
| K810356 | BICARBONATE TEST | Boehringer Mannheim Corp. | 1981-02-23 | Traditional | PDF ↗ |
| K771507 | MULTISTAT III BICARBONATE TEST | Instrumentation Laboratory CO | 1977-10-25 | Traditional | PDF ↗ |
| K760546 | REAGENT KIT, ENZYMATIC CO2 | Beckman Instruments, Inc. | 1976-11-01 | Traditional | PDF ↗ |
Product code KHS · Class II · Clinical Chemistry. Data: openFDA.