Product code KHS— Clinical Chemistry
CARBON DIOXIDE REAGENT
- Classification name
- Enzymatic, Carbon-Dioxide
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Total cleared
- 86
- First cleared
- Most recent
Market context for product code KHS
FDA has cleared devices under product code KHS between 1976 and 2017, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2004
- 2003
- 2001
- 2000
Top applicants under product code KHS
Recent clearances under product code KHS
- K170200 — Carbon Dioxide Reagent Set
- K152085 — Liquid CO2-2 (LCO2-2)
- K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
- K131546 — AU BICARBONATE REAGENT
- K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
- K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- K111960 — ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
- K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
- K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
- K093611 — VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002
- K091153 — SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
- K073223 — S-TEST C02
- K071340 — CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
- K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT
- K060619 — DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
- K061238 — DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
- K060295 — CARBON DIOXIDE
- K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
- K032377 — ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
- K031879 — COBAS INTEGRA CARBON DIOXIDE ASSAY
- K012332 — JAS CARBON DIOXIDE LIQUID REAGENT
- K010864 — ANALYST PANELS + ANALYTICAL TEST ROTOR
- K010206 — DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
- K002354 — CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
- K001133 — VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
- K992475 — CARESIDE CO2, TOTAL
- K991108 — CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
- K990754 — CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
- K983019 — CARBON DIOXIDE-SL ASSAY, CAT # 253-01
- K982056 — RAICHEM CO2 REAGENT
- K981840 — CO2
- K980996 — COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
- K981231 — CO2
- K960035 — CARBON DIOXIDE - DST
- K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT
- K955302 — SERUM BICARBONATE/CARBON DIOXIDE
- K951221 — TOTAL CO2
- K952410 — CARBON DIOXIDE - DST
- K942735 — CARBON DIOXIDE (C02)
- K933461 — BOEHRINGER MANNHEIM BICARBONATE ASSAY
- K941156 — TECHNISON AXON SYSTEM
- K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION
- K931887 — BICARBONATE
- K924428 — SYNERMED ENZYMATIC CO2 REAGENT KIT
- K924711 — BICARBONATE
- K914486 — COULTER CARBON DIOXIDE REAGENT
- K912806 — ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
- K903409 — SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
- K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
- K903144 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
- K904007 — BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
- K902229 — COULTER CARBON DIOXIDE REAGENT
- K896812 — CARBON DIOXIDE REAGENT
- K896258 — CO2 REAGENT (340 NM)
- K896590 — CARBON DIOXIDE REAGENT
- K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
- K894509 — BICARBONATE TEST ITEM NUMBER: 65412
- K891991 — BICARBONATE; SYSTEM PACK REAGENTS
- K890305 — BICARBONATE TEST ITEM NUMBER: SR1006
- K884821 — ABBOTT SPECTRUM(R) BICARBONATE REAGENT
- K880868 — CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
- K883055 — DART CARBON DIOXIDE
- K882497 — ENZYMATIC CO2 REAGENT SET
- K881938 — BICARBONATE (CO2) REAGENT-2 VIAL
- K880866 — CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
- K881169 — CARBON DIOXIDE REAGENT
- K880794 — RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
- K880609 — ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
- K880268 — CO2 REAGENT
- K874941 — BIOTROL BICARBONATE (CO2) UV HP)
- K874435 — BICARBONATE
- K872108 — ABBOTT SPECTRUM BICARBONATE REAGENT KIT
- K870062 — BICARBONATE PROCEDURE
- K863544 — EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
- K861673 — BICARBONATE PROCEDURE
- K854544 — RAICHEM CO2 REAGENT
- K850903 — DATA ZYME CO2 PROCEDURE
- K844987 — ROCHE REAGENTS REAGENT FOR CO2
- K841664 — ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
- K841726 — DEMAND C02
- K840773 — CARBON DIOXIDE REAGENT
- K822079 — ENZYMATIC CO2
- K810356 — BICARBONATE TEST
- K771507 — MULTISTAT III BICARBONATE TEST
- K760546 — REAGENT KIT, ENZYMATIC CO2
Data sourced from openFDA. This site is unofficial and independent of the FDA.