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)
Top companies in CHL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2015 | Roche 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 |
CHL | K032311 |
| Jun 27, 2015 | LifeHealth, 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 |
CHL | K945240 |
| Oct 10, 2014 | Roche 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 |
CHL | K032311 |
| Mar 27, 2014 | Abbott 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 |
CHL | K940918 |
| Feb 24, 2014 | Radiometer 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 |
CHL | K041874 K980130 |
| Jan 10, 2014 | Radiometer 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 |
CHL | K895181 K922922 +1 |
| Oct 29, 2013 | Siemens 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 |
CHL | K073537 |
| Oct 29, 2013 | Siemens 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 |
CHL | K073537 |
| Oct 29, 2013 | Siemens 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 |
CHL | K031560 |
| Oct 29, 2013 | Siemens 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 |
CHL | K031560 |
| Oct 29, 2013 | Siemens 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 |
CHL | K113216 |
| Oct 29, 2013 | Siemens 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 |
CHL | K110277 |
| Oct 29, 2013 | Siemens 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 |
CHL | K002738 |
| Dec 13, 2012 | Roche 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 |
CHL | K111188 |
| Nov 5, 2012 | Sendx 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 |
CHL | K080370 |
| Sep 21, 2012 | OPTI 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 |
CHL | K093280 |
| Aug 30, 2012 | Sendx 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 |
CHL | K051804 K080370 |
| Aug 8, 2012 | Radiometer 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 |
CHL | K120197 |
| Aug 8, 2012 | Radiometer 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 |
CHL | K002290 K041874 +4 |
| Aug 8, 2012 | Radiometer 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 |
CHL | K002290 K041874 +4 |
| Aug 2, 2012 | Abbott 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 |
CHL | K940918 |
| Jul 9, 2012 | Abbott 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 |
CHL | K001387 |
| Jul 9, 2012 | Abbott 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 |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott 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 |
CHL | K001387 |
| Jul 9, 2012 | Abbott 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 |
CHL | K001387 |
| Jul 9, 2012 | Abbott 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 |
CHL | K001387 |
| Apr 9, 2012 | Sendx 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 |
CHL | K051804 |
| Jun 27, 2011 | Instrumentation 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 |
CHL | K052121 |
| Mar 10, 2011 | Abbott 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 |
CHL | K940918 |
| Jan 20, 2011 | Abbott 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 |
CHL | K940918 |
| Jan 20, 2011 | Abbott 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 |
CHL | K940918 |
| Dec 10, 2010 | Abbott 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 |
CHL | K940918 |
| Dec 10, 2010 | Abbott 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 |
CHL | K940918 |
| Dec 10, 2010 | Abbott 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 |
CHL | K940918 |
| Dec 10, 2010 | Abbott 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 |
CHL | K940918 |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT BNP cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | K053597 |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT CK-MB cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | K051433 |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT cTnl cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | K051433 |
| Mar 8, 2010 | Siemens 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 |
CHL | K002738 |
| Mar 8, 2010 | Siemens 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 |
CHL | K002738 |
| Nov 10, 2009 | Sendx 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 |
CHL | K080370 |
| Jul 15, 2009 | Radiometer 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 |
CHL | K002290 K041874 |
| Jun 18, 2009 | Abbott 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 |
CHL | K940918 |
| Jun 18, 2009 | Abbott 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 |
CHL | K894914 K912387 +2 |
| Jan 18, 2008 | Radiometer America Inc ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) Terminated |
CHL | K041874 |
| Jan 18, 2008 | Radiometer America Inc ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). Terminated |
CHL | K002290 |
| Oct 11, 2007 | Radiometer 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 |
CHL | K041874 |
| Aug 29, 2007 | Sendx Medical Inc ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 Terminated |
CHL | K051804 |
| Aug 25, 2007 | Sendx Medical Inc ABL80 FLEX Analyzer, Model #393-839 Terminated |
CHL | None listed |
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