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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

Company510(k)sRecalls
Instrumentation Laboratory CO1635
Radiometer America, Inc.1530
Siemens Healthcare Diagnostics241
Nova Biomedical Corp.2811
Abbott Point of Care, Inc.431
Radiometer Medical Aps1315
Fisher Scientific Co., LLC150
Avl Scientific Corp.120
Sendx Medical, Inc.47
Ciba Corning Diagnostics Corp.70
Decided510(k)Device and applicantCode
Apr 10, 2026K252207ABL90 FLEX PLUS System, safeCLINITUBES
Radiometer Medicals Aps, DK
CHL
May 2, 2025K244014i-STAT CG4+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Dec 13, 2024K240998ABL90 FLEX PLUS System
Radiometer Medicals Aps, DK
CHL
Oct 27, 2023K230285i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Sep 29, 2023K221900Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
CHL
Sep 15, 2023K223857i-STAT G3+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Aug 10, 2023K223608GEM Premier 7000 with IQM3
Instrumentation Laboratory Company
CHL
Jan 27, 2023K211559EasyStat 300
Medica Corporation
CHL
Aug 20, 2021K203790GEM Premier 5000
Instrumentation Laboratory CO
CHL
Aug 2, 2021K200986OPTI® B-Lac Cassette
Opti Medical Systems, Inc.
CHL
Jun 5, 2020K200107epoc Blood Analysis System
Epocal, Inc., CA
CHL
Apr 9, 2020K200492i-STAT CG4+ Cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Mar 27, 2020K192240RAPIDPoint 500e Blood Gas System
Siemens Healthcare Diagnostics, Inc.
CHL
Jan 24, 2020K193246Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
CHL
Jul 17, 2018K173797Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
CHL
Dec 29, 2017K173403GEM Premier 5000
Instrumentation Laboratory CO
CHL
Dec 14, 2016K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
Instrumentation Laboratory CO
CHL
Nov 4, 2016K160153ABL90 FLEX PLUS
Radiometer Medical Aps, DK
CHL
Jul 15, 2016K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Cont
Edan Instruments, Inc., CN
CHL
Sep 10, 2015K151982Stat Profile Prime ABG Analyzer System
Nova Biomedical Corporation
CHL
Aug 6, 2015K151856ABL80 FLEX CO-OX with AQURE connectivity
Sendx Medical, Inc.
CHL
Jun 17, 2015K142898ABL800 FLEX with AQURE connectivity
Radiometer Medical Aps, DK
CHL
May 29, 2015K141907STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG
Nova Biomedical Corporation
CHL
Oct 17, 2014K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
Nova Biomedical Corporation
CHL
Mar 25, 2014K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
Nova Biomedical Corporation
CHL
Jan 13, 2014K133407GEM PREMIER 4000
Instrumentation Laboratory CO
CHL
Sep 17, 2013K131988ABL90 FLEX ANALYZER
Radiometer Medical Aps, DK
CHL
Aug 22, 2013K131126OPTI CCA-TS2
Opti Medical Systems, Inc.
CHL
Jul 31, 2013K130144ABL90 FLEX
Radiometer Medical Aps, DK
CHL
May 7, 2013K123748ABL90 FLEX
Radiometer Medical Aps, DK
CHL
Apr 19, 2013K122539MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
Siemens Healthcare Diagnostics
CHL
Nov 16, 2012K122729ABL90 FLEX
Radiometer Medical Aps, DK
CHL
Oct 26, 2012K122642ABL90 FLEX
Radiometer Medical Aps, DK
CHL
May 14, 2012K111188COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
Roche Diagnostics
CHL
Mar 19, 2012K120197ABL90 FLEX
Radiometer Medical Aps, DK
CHL
Aug 29, 2011K110648NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Nova Biomedical Corporation
CHL
Jul 19, 2011K111897ABL90
Radiometer Medical Aps, DK
CHL
Mar 24, 2011K110416ABL835 FLEX ANALYZER WITH PLEURAL PH
Radiometer Medical Aps, DK
CHL
Jan 7, 2011K093280OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
Opti Medical Systems, Inc.
CHL
Dec 10, 2010K100777ABL837 FLEX ANALYZER
Radiometer Medical Aps, DK
CHL
Jul 31, 2008K080370ABL 80 CO-OX SYSTEM
Sendx Medical, Inc.
CHL
Jun 25, 2007K063376EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
Medica Corp.
CHL
Sep 15, 2006K061974GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
Instrumentation Laboratory CO
CHL
Nov 1, 2005K051804ABL80 FLEX ANALYZER
Sendx Medical, Inc.
CHL
May 10, 2005K043218ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
Radiometer Medical Aps, DK
CHL
Apr 22, 2005K050423OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
Roche Diagnostics
CHL
Oct 8, 2004K041874ABL800 FLEX
Radiometer Medical Aps, DK
CHL
Dec 17, 2003K031560BAYER RAPIDLAB 1200 SYSTEM
Bayer Healthcare, LLC
CHL
Dec 20, 2002K023567STAT PROFILE PHOX PLUS L ANALYZER
Nova Biomedical Corp.
CHL
Nov 22, 2002K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZER
Nova Biomedical Corp.
CHL

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