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Panels › Clinical Chemistry › Product code KHS · Class 2

Enzymatic, Carbon-Dioxide

Regulation 862.1160

0510(k)s in 12 months (86 all time)
1recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in KHS

Company510(k)sRecalls
Diagnostic Chemicals , Ltd.70
Em Diagnostic Systems, Inc.70
Ortho-Clinical Diagnostics, Inc.32
Abbott Laboratories40
Beckman Coulter, Inc.13
Boehringer Mannheim Corp.40
Data Medical Associates, Inc.40
Pointe Scientific, Inc.,30
Trace America, Inc.30
Alfa Wassermann Diagnostic Technologies, Inc.20
Decided510(k)Device and applicantCode
Jun 1, 2017K170200Carbon Dioxide Reagent Set
Teco Diagnostics, Inc.
KHS
Feb 24, 2016K152085Liquid CO2-2 (LCO2-2)
Randox Laboratories, Ltd., GB
KHS
Mar 11, 2014K140248S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
Hitachi Chemical Diagnostics, Inc.
KHS
Oct 9, 2013K131546AU BICARBONATE REAGENT
Beckman Coulter Ireland, Inc.
KHS
May 2, 2013K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
KHS
Oct 24, 2012K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Ortho-Clinical Diagnostics, Inc.
KHS
Jul 2, 2012K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
Alfa Wassermann
KHS
Nov 18, 2011K111960ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
Elitechgroup
KHS
Dec 15, 2010K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
Vital Diagnostics (Manufacturing) Ptyltd, AU
KHS
May 10, 2010K100289ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
Siemens Healthcare Diagnostics
KHS
Apr 15, 2010K093611VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
Ortho-Clinical Diagnostics, Inc.
KHS
Jul 13, 2009K091153SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
Beckman Coulter, Inc.
KHS
Jun 26, 2008K073223S-TEST C02
Alfa Wassermann Diagnostic Technologies, Inc.
KHS
Oct 5, 2007K071340CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
Thermofisher Scientific OY, FI
KHS
Apr 30, 2007K070251CARBON DIOXIDE LIQUID STABLE REAGENT
Pointe Scientific, Inc.,
KHS
Jul 21, 2006K060619DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
Diazyme Laboratories
KHS
May 25, 2006K061238DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
KHS
May 4, 2006K060295CARBON DIOXIDE
Abbott Laboratories
KHS
Dec 27, 2004K042362MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
Diagnostic Chemicals , Ltd., CA
KHS
Aug 21, 2003K032377ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
Roche Diagnostics Corp.
KHS
Jul 17, 2003K031879COBAS INTEGRA CARBON DIOXIDE ASSAY
Roche Diagnostics Corp.
KHS
Sep 6, 2001K012332JAS CARBON DIOXIDE LIQUID REAGENT
Jas Diagnostics, Inc.
KHS
May 21, 2001K010864ANALYST PANELS + ANALYTICAL TEST ROTOR
Hemagen Diagnostics, Inc.
KHS
Mar 16, 2001K010206DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
Dade Behring, Inc.
KHS
Sep 26, 2000K002354CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
Diagnostic Chemicals , Ltd., CA
KHS
Apr 24, 2000K001133VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Ortho-Clinical Diagnostics, Inc.
KHS
Sep 15, 1999K992475CARESIDE CO2, TOTAL
Careside, Inc.
KHS
May 25, 1999K991108CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
A.P. Total Care, Inc.
KHS
Apr 20, 1999K990754CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
Diagnostic Chemicals , Ltd., CA
KHS
Sep 14, 1998K983019CARBON DIOXIDE-SL ASSAY, CAT # 253-01
Diagnostic Chemicals , Ltd., CA
KHS
Jun 24, 1998K982056RAICHEM CO2 REAGENT
Reagents Applications, Inc.
KHS
Jun 8, 1998K981840CO2
Abbott Laboratories
KHS
Jun 5, 1998K980996COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
Roche Diagnostic Systems, Inc.
KHS
May 12, 1998K981231CO2
Abbott Mfg., Inc.
KHS
Apr 8, 1996K960035CARBON DIOXIDE - DST
Trace America, Inc.
KHS
Mar 11, 1996K960793SYNERMED ENZYMATIC CO2 REAGENT KIT
Synermed, Inc., CA
KHS
Feb 29, 1996K955302SERUM BICARBONATE/CARBON DIOXIDE
Data Medical Associates, Inc.
KHS
Feb 15, 1996K951221TOTAL CO2
Randox Laboratories, Ltd., IR
KHS
Oct 5, 1995K952410CARBON DIOXIDE - DST
Trace America, Inc.
KHS
Mar 20, 1995K942735CARBON DIOXIDE (C02)
Teco Diagnostics
KHS
Dec 5, 1994K933461BOEHRINGER MANNHEIM BICARBONATE ASSAY
Boehringer Mannheim Corp.
KHS
Apr 26, 1994K941156TECHNISON AXON SYSTEM
Miles, Inc.
KHS
Sep 24, 1993K932267ENZYMATIC CO2 REAGENT, MODIFICATION
Intersect Systems, Inc.
KHS
Aug 3, 1993K931887BICARBONATE
Em Diagnostic Systems, Inc.
KHS
Dec 3, 1992K924711BICARBONATE
Em Diagnostic Systems, Inc.
KHS
Dec 3, 1992K924428SYNERMED ENZYMATIC CO2 REAGENT KIT
Synermed, Inc., CA
KHS
Nov 27, 1991K914486COULTER CARBON DIOXIDE REAGENT
Coulter Corp.
KHS
Sep 11, 1991K912806ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
Em Diagnostic Systems, Inc.
KHS
Oct 4, 1990K903409SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
Em Diagnostic Systems, Inc.
KHS
Sep 27, 1990K903305TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
Technicon Instruments Corp.
KHS

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