FDA 510(k) Applications for Medical Device Product Code "CHL"
(Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223857 | ABBOTT POINT OF CARE, INC | i-STAT G3+ cartridge with the i-STAT 1 System | 09/15/2023 |
| K200492 | Abbott point of Care, Inc. | i-STAT CG4+ Cartridge with the i-STAT 1 System | 04/09/2020 |
| K963964 | AVL SCIENTIFIC CORP. | AVL COMPACT 3 PH/BLOOD GAS ANALYZER | 11/29/1996 |
| K990092 | AVL SCIENTIFIC CORP. | AVL OMNI MODULAR ANALYZER | 01/29/1999 |
| K961161 | AVL SCIENTIFIC CORP. | AVL OPTI 1 PH/BLOOD GAS ANALYZER | 04/26/1996 |
| K000103 | AVL SCIENTIFIC CORP. | AVL OPTI R ANALYZER | 03/20/2000 |
| K002738 | BAYER CORP. | BAYER RAPIDPOINT 400 SYSTEM | 12/19/2000 |
| K031560 | BAYER HEALTHCARE, LLC | BAYER RAPIDLAB 1200 SYSTEM | 12/17/2003 |
| K962021 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING 348 SYSTEM | 06/24/1996 |
| K961657 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING 400 SYSTEM | 06/25/1996 |
| K980523 | DIAMETRICS MEDICAL, INC. | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE | 03/19/1998 |
| K974396 | DIAMETRICS MEDICAL, INC. | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE | 12/18/1997 |
| K151978 | EDAN INSTRUMENTS, INC. | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | 07/15/2016 |
| K200107 | Epocal Inc. | epoc Blood Analysis System | 06/05/2020 |
| K993789 | GENERAL AIR SERVICE AND SUPPLY | CLINICAL BLOOD GAS MIXTURE | 01/10/2000 |
| K012478 | I-STAT CORP. | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER | 08/20/2001 |
| K992834 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 3000 | 11/24/1999 |
| K133407 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 4000 | 01/13/2014 |
| K061974 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT | 09/15/2006 |
| K173403 | Instrumentation Laboratory Co. | GEM Premier 5000 | 12/29/2017 |
| K203790 | Instrumentation Laboratory Co. | GEM Premier 5000 | 08/20/2021 |
| K160412 | Instrumentation Laboratory Co. | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | 12/14/2016 |
| K955793 | INSTRUMENTATION LABORATORY CO. | IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM | 02/14/1996 |
| K963800 | INSTRUMENTATION LABORATORY CO. | IL SYNTHESIS | 11/13/1996 |
| K223608 | Instrumentation Laboratory Company | GEM Premier 7000 with IQM3 | 08/10/2023 |
| K961335 | MALLINCKRODT SENSOR SYSTEMS, INC. | GEM PREMIER PLUS MODEL 5500 | 06/28/1996 |
| K974526 | MEDICA CORP. | EASYBLOOD GAS ANALYZER | 02/05/1998 |
| K021515 | MEDICA CORP. | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER | 07/16/2002 |
| K063376 | MEDICA CORP. | EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER | 06/25/2007 |
| K211559 | Medica Corporation | EasyStat 300 | 01/27/2023 |
| K982277 | NOVA BIOMEDICAL CORP. | MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) | 07/22/1998 |
| K002613 | NOVA BIOMEDICAL CORP. | MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER | 10/19/2000 |
| K980991 | NOVA BIOMEDICAL CORP. | NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER | 04/15/1998 |
| K020297 | NOVA BIOMEDICAL CORP. | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | 06/10/2002 |
| K022746 | NOVA BIOMEDICAL CORP. | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | 11/22/2002 |
| K014295 | NOVA BIOMEDICAL CORP. | STAT PROFILE PHOX ANALYZER | 02/28/2002 |
| K013729 | NOVA BIOMEDICAL CORP. | STAT PROFILE PHOX BASIC ANALYZER | 01/15/2002 |
| K021713 | NOVA BIOMEDICAL CORP. | STAT PROFILE PHOX PLUS C ANALYZER | 07/25/2002 |
| K012058 | NOVA BIOMEDICAL CORP. | STAT PROFILE PHOX PLUS L ANALYZER | 08/20/2001 |
| K023567 | NOVA BIOMEDICAL CORP. | STAT PROFILE PHOX PLUS L ANALYZER | 12/20/2002 |
| K970710 | NOVA BIOMEDICAL CORP. | STAT PROFILE ULTRA M ANALYZER | 05/09/1997 |
| K110648 | NOVA BIOMEDICAL CORPORATION | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM | 08/29/2011 |
| K131703 | NOVA BIOMEDICAL CORPORATION | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | 03/25/2014 |
| K151982 | NOVA BIOMEDICAL CORPORATION | Stat Profile Prime ABG Analyzer System | 09/10/2015 |
| K142220 | NOVA BIOMEDICAL CORPORATION | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) | 10/17/2014 |
| K141907 | NOVA BIOMEDICAL CORPORATION | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A | 05/29/2015 |
| K173797 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 07/17/2018 |
| K221900 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 09/29/2023 |
| K193246 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 01/24/2020 |
| K093280 | OPTI MEDICAL SYSTEMS INC. | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | 01/07/2011 |
| K131126 | OPTI MEDICAL SYSTEMS INC. | OPTI CCA-TS2 | 08/22/2013 |
| K200986 | OPTI Medical Systems, Inc. | OPTI« B-Lac Cassette | 08/02/2021 |
| K991417 | RADIOMETER AMERICA, INC. | ABL 735 ANALYZER | 11/24/1999 |
| K973367 | RADIOMETER AMERICA, INC. | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | 10/06/1997 |
| K992859 | RADIOMETER AMERICA, INC. | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | 01/10/2000 |
| K980130 | RADIOMETER AMERICA, INC. | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | 02/09/1998 |
| K982928 | RADIOMETER AMERICA, INC. | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | 01/06/1999 |
| K002290 | RADIOMETER MEDICAL A/S | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | 09/13/2000 |
| K041874 | RADIOMETER MEDICAL APS | ABL800 FLEX | 10/08/2004 |
| K043218 | RADIOMETER MEDICAL APS | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX | 05/10/2005 |
| K110416 | RADIOMETER MEDICAL APS | ABL835 FLEX ANALYZER WITH PLEURAL PH | 03/24/2011 |
| K100777 | RADIOMETER MEDICAL APS | ABL837 FLEX ANALYZER | 12/10/2010 |
| K111897 | RADIOMETER MEDICAL APS | ABL90 | 07/19/2011 |
| K120197 | RADIOMETER MEDICAL APS | ABL90 FLEX | 03/19/2012 |
| K122642 | RADIOMETER MEDICAL APS | ABL90 FLEX | 10/26/2012 |
| K122729 | RADIOMETER MEDICAL APS | ABL90 FLEX | 11/16/2012 |
| K123748 | RADIOMETER MEDICAL APS | ABL90 FLEX | 05/07/2013 |
| K130144 | RADIOMETER MEDICAL APS | ABL90 FLEX | 07/31/2013 |
| K131988 | RADIOMETER MEDICAL APS | ABL90 FLEX ANALYZER | 09/17/2013 |
| K160153 | RADIOMETER MEDICAL APS | ABL90 FLEX PLUS | 11/04/2016 |
| K142898 | Radiometer Medical Aps. | ABL800 FLEX with AQURE connectivity | 06/17/2015 |
| K111188 | Roche Diagnostics | COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B | 05/14/2012 |
| K050423 | Roche Diagnostics | OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) | 04/22/2005 |
| K151856 | SENDX MEDICAL INC. | ABL80 FLEX CO-OX with AQURE connectivity | 08/06/2015 |
| K994346 | SENDX MEDICAL, INC. | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | 02/01/2000 |
| K080370 | SENDX MEDICAL, INC. | ABL 80 CO-OX SYSTEM | 07/31/2008 |
| K051804 | SENDX MEDICAL, INC. | ABL80 FLEX ANALYZER | 11/01/2005 |
| K122539 | SIEMENS HEALTHCARE DIAGNOSTICS | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | 04/19/2013 |
| K192240 | Siemens Healthcare Diagnostics, Inc. | RAPIDPoint 500e Blood Gas System | 03/27/2020 |
| K984384 | THERMO BIOANALYSIS CORP. | 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 | 12/23/1998 |
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