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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 18, 2007Sendx Medical Inc
ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
Terminated
CHLK994346
Jul 24, 2007Radiometer America Inc
ABL 800 FLEX series blood gas analyzers containing software version 5.24.
Terminated
CHLK041874
Jul 24, 2007Radiometer America Inc
ABL 700 Series blood gas analyzers equipped with Software Version 3.833.
Terminated
CHLK002290
May 3, 2007Instrumentation Laboratory Co.
GEM Premier 4000 Laboratory Analyzer
Terminated
CHLK061974
Apr 6, 2007Radiometer America Inc
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Terminated
CHLK043218
Aug 29, 2006Siemens Healthcare Diagnostics
RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Terminated
CHLK031560
Aug 29, 2006Siemens Healthcare Diagnostics
RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
Terminated
CHLK031560
Aug 29, 2006Radiometer America Inc
S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
Terminated
CHLNone listed
Aug 26, 2006Radiometer America Inc
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Terminated
CHLK982928
Aug 3, 2006Radiometer America Inc
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.
Terminated
CHLK041874
Aug 3, 2006Radiometer America Inc
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Terminated
CHLK041874
Aug 3, 2006Radiometer America Inc
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
Terminated
CHLK980130
Aug 3, 2006Radiometer America Inc
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
Terminated
CHLK943882
Aug 2, 2006Radiometer America Inc
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Terminated
CHLK041874
Aug 2, 2006Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
Terminated
CHLK041874
Aug 2, 2006Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
Terminated
CHLK002290
K991417 +1
Jul 27, 2006Radiometer America Inc
Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.
Terminated
CHLK982928
Jul 26, 2006Radiometer America Inc
Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits
Terminated
CHLNone listed
Mar 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy
Terminated
CHLK031560
Mar 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy
Terminated
CHLK031560
Mar 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys
Terminated
CHLK031560
Mar 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys
Terminated
CHLK031560
Feb 28, 2006Nova Biomedical Corporation
CCX Operating Software , Version 4.08
Terminated
CHLNone listed
Feb 28, 2006Nova Biomedical Corporation
Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413
Terminated
CHLK022746
Feb 28, 2006Nova Biomedical Corporation
Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
Terminated
CHLK020297
Jul 20, 2004Nova Biomedical Corporation
ABG Replacement Pump Assembly Catalog Number: 37092
Terminated
CHLNone listed
Jul 20, 2004Nova Biomedical Corporation
Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished
Terminated
CHLNone listed
Jul 20, 2004Nova Biomedical Corporation
Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished
Terminated
CHLNone listed
Jul 20, 2004Nova Biomedical Corporation
Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
Terminated
CHLNone listed
Jul 20, 2004Nova Biomedical Corporation
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
Terminated
CHLK022746
Oct 24, 2003Bayer Corp.
Bayer Rapidpoint 405 Blood Gas Analyzer
Terminated
CHLK020616
Oct 24, 2003Nova Biomedical Corporation
Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer) Part # 37271
Terminated
CHLK022746
Oct 24, 2003Nova Biomedical Corporation
Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
Terminated
CHLK981427
May 20, 2003Instrumentation Laboratory Co.
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Terminated
CHLK992834
May 20, 2003Instrumentation Laboratory Co.
GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Terminated
CHLK992834

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