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Panels › Clinical Chemistry › Product code CHL · Class 2

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Regulation 862.1120

1510(k)s in 12 months (188 all time)
33recalls in 12 months (185 all time)
173recalls that name a 510(k)
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Top companies in CHL

DateFirm and productCodeLinked 510(k)
Aug 5, 2015Roche Diagnostics Operations, Inc.
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to
Terminated
CHLK032311
Jun 27, 2015LifeHealth, LLC
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2,
Terminated
CHLK945240
Oct 10, 2014Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2
Terminated
CHLK032311
Mar 27, 2014Abbott Point Of Care Inc.
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Terminated
CHLK940918
Feb 24, 2014Radiometer America Inc
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in w
Terminated
CHLK041874
K980130
Jan 10, 2014Radiometer America Inc
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (par
Terminated
CHLK895181
K922922 +1
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitat
Terminated
CHLK073537
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitat
Terminated
CHLK073537
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantita
Terminated
CHLK031560
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitat
Terminated
CHLK031560
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This sy
Terminated
CHLK113216
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and he
Terminated
CHLK110277
Oct 29, 2013Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hem
Terminated
CHLK002738
Dec 13, 2012Roche Diagnostics Operations, Inc.
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolit
Terminated
CHLK111188
Nov 5, 2012Sendx Medical Inc
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximet
Terminated
CHLK080370
Sep 21, 2012OPTI Medical Systems, Inc
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total
Terminated
CHLK093280
Aug 30, 2012Sendx Medical Inc
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with
Terminated
CHLK051804
K080370
Aug 8, 2012Radiometer America Inc
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Terminated
CHLK120197
Aug 8, 2012Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, c
Terminated
CHLK002290
K041874 +4
Aug 8, 2012Radiometer America Inc
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, c
Terminated
CHLK002290
K041874 +4
Aug 2, 2012Abbott Point Of Care Inc.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, parti
Terminated
CHLK940918
Jul 9, 2012Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 2
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as por
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analy
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the
Terminated
CHLK001387
Apr 9, 2012Sendx Medical Inc
SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit
Terminated
CHLK051804
Jun 27, 2011Instrumentation Laboratory Co.
Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whol
Terminated
CHLK052121
Mar 10, 2011Abbott Point Of Care Inc.
i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pres
Terminated
CHLK940918
Jan 20, 2011Abbott Point of Care Inc.
i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in ar
Terminated
CHLK940918
Jan 20, 2011Abbott Point of Care Inc.
i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable ana
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analy
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer
Terminated
CHLK940918
Nov 3, 2010Abbott Point Of Care Inc.
i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK053597
Nov 3, 2010Abbott Point Of Care Inc.
i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK051433
Nov 3, 2010Abbott Point Of Care Inc.
i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK051433
Mar 8, 2010Siemens Healthcare Diagnostics Inc
RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. The Siemens 400 series system is intended for point of care and laboratory tes
Terminated
CHLK002738
Mar 8, 2010Siemens Healthcare Diagnostics Inc
RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.1. The Siemens 400 series system is intended for point of care and laboratory testing of blood gase
Terminated
CHLK002738
Nov 10, 2009Sendx Medical Inc
ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that me
Terminated
CHLK080370
Jul 15, 2009Radiometer America Inc
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
Terminated
CHLK002290
K041874
Jun 18, 2009Abbott Point of Care Inc.
i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. Abbott Point of Care Inc., Abbott Pa
Terminated
CHLK940918
Jun 18, 2009Abbott Point of Care Inc.
i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, E
Terminated
CHLK894914
K912387 +2
Jan 18, 2008Radiometer America Inc
ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Terminated
CHLK041874
Jan 18, 2008Radiometer America Inc
ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).
Terminated
CHLK002290
Oct 11, 2007Radiometer America Inc
Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Terminated
CHLK041874
Aug 29, 2007Sendx Medical Inc
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
Terminated
CHLK051804
Aug 25, 2007Sendx Medical Inc
ABL80 FLEX Analyzer, Model #393-839
Terminated
CHLNone listed

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