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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