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 18, 2007 | Sendx Medical Inc ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company Terminated |
CHL | K994346 |
| Jul 24, 2007 | Radiometer America Inc ABL 800 FLEX series blood gas analyzers containing software version 5.24. Terminated |
CHL | K041874 |
| Jul 24, 2007 | Radiometer America Inc ABL 700 Series blood gas analyzers equipped with Software Version 3.833. Terminated |
CHL | K002290 |
| May 3, 2007 | Instrumentation Laboratory Co. GEM Premier 4000 Laboratory Analyzer Terminated |
CHL | K061974 |
| Apr 6, 2007 | Radiometer America Inc ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 Terminated |
CHL | K043218 |
| Aug 29, 2006 | Siemens Healthcare Diagnostics RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division Terminated |
CHL | K031560 |
| Aug 29, 2006 | Siemens Healthcare Diagnostics RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division Terminated |
CHL | K031560 |
| Aug 29, 2006 | Radiometer 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 |
CHL | None listed |
| Aug 26, 2006 | Radiometer America Inc D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers. Terminated |
CHL | K982928 |
| Aug 3, 2006 | Radiometer America Inc Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box. Terminated |
CHL | K041874 |
| Aug 3, 2006 | Radiometer America Inc ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. Terminated |
CHL | K041874 |
| Aug 3, 2006 | Radiometer America Inc Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box. Terminated |
CHL | K980130 |
| Aug 3, 2006 | Radiometer 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 |
CHL | K943882 |
| Aug 2, 2006 | Radiometer America Inc D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. Terminated |
CHL | K041874 |
| Aug 2, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series. Terminated |
CHL | K041874 |
| Aug 2, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. Terminated |
CHL | K002290 K991417 +1 |
| Jul 27, 2006 | Radiometer America Inc Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device. Terminated |
CHL | K982928 |
| Jul 26, 2006 | Radiometer 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 |
CHL | None listed |
| Mar 29, 2006 | Bayer 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 |
CHL | K031560 |
| Mar 29, 2006 | Bayer 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 |
CHL | K031560 |
| Mar 29, 2006 | Bayer 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 |
CHL | K031560 |
| Mar 29, 2006 | Bayer 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 |
CHL | K031560 |
| Feb 28, 2006 | Nova Biomedical Corporation CCX Operating Software , Version 4.08 Terminated |
CHL | None listed |
| Feb 28, 2006 | Nova Biomedical Corporation Stat Profile Critical Care PLUS (CCX) Analyzer
Catalog Number: 37413 Terminated |
CHL | K022746 |
| Feb 28, 2006 | Nova Biomedical Corporation Stat Profile Critical Care (CCX) Analyzer
Catalog Number: 35942 Terminated |
CHL | K020297 |
| Jul 20, 2004 | Nova Biomedical Corporation ABG Replacement Pump Assembly
Catalog Number: 37092 Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX+ (R) Anaylzer
Catalog NUmber: 37555
R= Refurbished Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX (R) Analyzer
Catalog Number: 37562
R= Refurbished Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX+ Analyzer
Catalog Number: 37413 Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX) Analyzer
Catalog Number: 35942 Terminated |
CHL | K022746 |
| Oct 24, 2003 | Bayer Corp. Bayer Rapidpoint 405 Blood Gas Analyzer Terminated |
CHL | K020616 |
| Oct 24, 2003 | Nova 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 |
CHL | K022746 |
| Oct 24, 2003 | Nova Biomedical Corporation Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer)
Part # 20394 Terminated |
CHL | K981427 |
| May 20, 2003 | Instrumentation 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 |
CHL | K992834 |
| May 20, 2003 | Instrumentation 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 |
CHL | K992834 |
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