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
K771253 3M COMPANY HEMOX-ANALYZER 08/25/1977
K884267 ALKO DIAGNOSTIC CORP. ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS 05/04/1989
K760748 ALKO SCIENTIFIC CO. REAGENTS FOR BLOOD GAS INSTRUMENTATION 11/01/1976
K852676 ALLIED INSTRUMENTATION LABORATORY IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS 07/22/1985
K810308 AMERICAN DADE ARTERIAL MICROCOLLECTION SET 02/19/1981
K832981 ANALYTICAL PRODUCTS, INC. ELECTRODES FOR BLOOD GAS ANALYZERS 10/28/1983
K832779 ANALYTICAL PRODUCTS, INC. REFEREE BLOOD GAS ANALYZER-ELECTRODES 10/14/1983
K932642 AVL SCIENTIFIC CORP. AVL 9110PH ANALYZER 10/14/1993
K943570 AVL SCIENTIFIC CORP. AVL COMPACT 1 PH/BLOOD GAS ANALYZER 08/24/1994
K942616 AVL SCIENTIFIC CORP. AVL COMPACT 2 PH/BLOOD GAS ANALYZER 07/28/1994
K963964 AVL SCIENTIFIC CORP. AVL COMPACT 3 PH/BLOOD GAS ANALYZER 11/29/1996
K834601 AVL SCIENTIFIC CORP. AVL MODEL 945 BLOOD GAS SYSTEM 03/09/1984
K891578 AVL SCIENTIFIC CORP. AVL MODEL 987 ELECTROLYTE ANALYZER 05/22/1989
K895317 AVL SCIENTIFIC CORP. AVL MODEL 995HB PH/BLOOD GAS ANALYZER 02/01/1990
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
K944089 AVL SCIENTIFIC CORP. AVL OPTI PH/BLOOD GAS ANALYZER 10/20/1994
K000103 AVL SCIENTIFIC CORP. AVL OPTI R ANALYZER 03/20/2000
K831379 AVL SCIENTIFIC CORP. MODEL 947 VIDEO BLOOD GAS SYS 07/28/1983
K002738 BAYER CORP. BAYER RAPIDPOINT 400 SYSTEM 12/19/2000
K031560 BAYER HEALTHCARE, LLC BAYER RAPIDLAB 1200 SYSTEM 12/17/2003
K840300 BIONOSTICS, INC. FLUSH SOLUTION CONCENTRATE-BLOOD GAS 03/23/1984
K840843 BIONOSTICS, INC. POTASSIUM CHLORIDE TABLETS 04/17/1984
K770736 CAVITRON CORP. MONITOR, PATIENT, MODEL PM-20N 06/02/1977
K934907 CIBA CORNING DIAGNOSTICS CORP. 860 MEASURMENT SYSTEM 01/03/1994
K935830 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING 248 PH/BLOOD GAS ANALYZER 02/03/1994
K962021 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING 348 SYSTEM 06/24/1996
K961657 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING 400 SYSTEM 06/25/1996
K946206 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING 8-- SERIES CO-OXIMETER 01/30/1995
K904188 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER 09/27/1990
K865036 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM 03/06/1987
K954482 CIRRUS MEDICAL,INC. SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM 12/04/1995
K820597 CORNING MEDICAL & SCIENTIFIC 158 BLOOD GAS ANALYZER 03/26/1982
K781968 CORNING MEDICAL & SCIENTIFIC BLOOD GAS SYSTEM MODEL 168 01/03/1979
K823570 CORNING MEDICAL & SCIENTIFIC CORNING 170 PH/BLOOD GAS ANALYZER 12/28/1982
K810724 CORNING MEDICAL & SCIENTIFIC CORNING 178 BLOOD GAS ANALYZER 03/31/1981
K863880 D.R.G. SCIENTIFIC INDUSTRIES BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. 11/24/1986
K945240 DIAMETRICS MEDICAL, INC. IRMA BLOOD ANALYSIS SYSTEM 01/05/1995
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
K915087 DIAMOND MEDICAL, INC. DMI BLOD GAS ANALYZER/CARTRIDGE 01/08/1992
K924758 DIAMOND MEDICAL, INC. DMI BLOOD GAS ANALYZER/CARTRIDGE 12/03/1992
K873577 DIAMOND SENSOR SYSTEMS GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK 04/28/1988
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
K831016 FISHER SCIENTIFIC CO., LLC. BATH CLEAR 05/05/1983
K831017 FISHER SCIENTIFIC CO., LLC. BUFFER PACK FOR ABL-1 & ABL-2 05/09/1983
K831018 FISHER SCIENTIFIC CO., LLC. CALIBRATING SOLUTION FOR ABL-1 & 2 06/16/1983
K831021 FISHER SCIENTIFIC CO., LLC. CALIBRATING SOLUTION FOR ABL-1 & 2 06/16/1983
K812623 FISHER SCIENTIFIC CO., LLC. CLEANING SOLUTION FOR RADIOMETER OSM2 11/02/1981
K831012 FISHER SCIENTIFIC CO., LLC. DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON 06/08/1983
K831015 FISHER SCIENTIFIC CO., LLC. DIAGNOSTICS PH ELECTRODE CLEANING SOLUT 05/25/1983
K831013 FISHER SCIENTIFIC CO., LLC. DIAGNOSTICS PO 2 ELECTROLYTE 06/08/1983
K831010 FISHER SCIENTIFIC CO., LLC. DIAGNOSTICS PO2 ELECTRODE CLEANER 05/05/1983
K831025 FISHER SCIENTIFIC CO., LLC. ELECTROLYLE CARBON DIOXIDE ELECTRODES 06/16/1983
K831024 FISHER SCIENTIFIC CO., LLC. ELECTROLYTE PO2 FOR OXYGEN ELECTRODES 06/16/1983
K831020 FISHER SCIENTIFIC CO., LLC. FLUSH SOLUTION CONCENTRATE 05/09/1983
K772307 FISHER SCIENTIFIC CO., LLC. PCO 2 ELECTROLYTE 12/22/1977
K831019 FISHER SCIENTIFIC CO., LLC. PH 6.838 REF. BUFFER 06/16/1983
K831023 FISHER SCIENTIFIC CO., LLC. REFERENCE BUFFER PH 7.382 06/15/1983
K792230 GAUNTLET TECHNOLOGY CORP. AVL MODEL 940 AUTOMATIC PH/BLOOD GAS 12/31/1979
K993789 GENERAL AIR SERVICE AND SUPPLY CLINICAL BLOOD GAS MIXTURE 01/10/2000
K881188 HELPS PRODUCTS, INC. BLOOD PH CAPILLARY TUBES, HEPARIN 07/08/1988
K853405 HORIBA INSTRUMENTS, INC. ELECTROLYTE ANALYZER SERA-252 12/04/1985
K940918 I-STAT CORP. I-STAT 200 PORTABLE CLINICAL ANALYZER 05/10/1994
K936081 I-STAT CORP. I-STAT TESTS FOR ACID-BASE PARAMETERS 02/24/1994
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
K160412 Instrumentation Laboratory Co. GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) 12/14/2016
K821483 INSTRUMENTATION LABORATORY CO. IL 1302 PH BLOOD GAS ANALYZER 06/10/1982
K913927 INSTRUMENTATION LABORATORY CO. IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST 10/11/1991
K955793 INSTRUMENTATION LABORATORY CO. IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM 02/14/1996
K820744 INSTRUMENTATION LABORATORY CO. IL MODEL 1301, PH BLOOD GAS SYSTEM 04/15/1982
K800757 INSTRUMENTATION LABORATORY CO. IL MODEL 1303 PH/BLOOD GAS ANALYZER 04/21/1980
K963800 INSTRUMENTATION LABORATORY CO. IL SYNTHESIS 11/13/1996
K890827 INSTRUMENTATION LABORATORY CO. IL1400, BGELECTROLYTE ANALYZER 06/20/1989
K935069 INSTRUMENTATION LABORATORY CO. IL1430 BGELECTROLYTE ANALYZER 03/28/1994
K760969 INSTRUMENTATION LABORATORY CO. PH/BLOOD GAS SYSTEM 01/12/1977
K771147 JONES MEDICAL INSTRUMENT CO. AVL BLOOD GAS INSTRUMENT MODEL 939 09/15/1977
K882209 LINDE DIV. UNION CARBIDE CORP. MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES 08/02/1988
K812090 LORENZ INSTRUMENTS LORENZ BLOOD GAS ANALYZER 11/10/1981
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
K953935 MEDICAL TECHNICAL GASES INC.. MED-TECH CLINICAL BLOOD GAS 11/20/1995
K854608 NOVA BIOMEDICAL CORP. ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. 12/05/1985
K852790 NOVA BIOMEDICAL CORP. ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT 11/12/1985
K871397 NOVA BIOMEDICAL CORP. ANALYZER: NOVA STAT PROFILE 3 ANALYZER 06/03/1987
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
K884143 NOVA BIOMEDICAL CORP. NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER 12/02/1988
K980991 NOVA BIOMEDICAL CORP. NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER 04/15/1998
K864445 NOVA BIOMEDICAL CORP. STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL 02/04/1987
K924497 NOVA BIOMEDICAL CORP. STAT PROFILE 9 ANALYZER 02/23/1993
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
K023567 NOVA BIOMEDICAL CORP. STAT PROFILE PHOX PLUS L ANALYZER 12/20/2002
K012058 NOVA BIOMEDICAL CORP. STAT PROFILE PHOX PLUS L ANALYZER 08/20/2001
K936203 NOVA BIOMEDICAL CORP. STAT PROFILE PLUS 10 ANALYZER 03/09/1995
K943643 NOVA BIOMEDICAL CORP. STAT PROFILE ULTRA 11 ANALYZER 12/29/1994
K954711 NOVA BIOMEDICAL CORP. STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) 11/30/1995
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
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
K902267 PHOENIX DIAGNOSTICS, INC. BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS 06/12/1990
K914560 PPG INDUSTRIES, INC. STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL 11/29/1991
K903965 PPG INDUSTRIES, INC. STATPAL BLOOD GAS MONITORING SYSTEM 12/26/1990
K922631 PPG INDUSTRIES, INC. STATPAL II BLOOD GAS ANALYSIS SYSTEM 11/10/1992
K991417 RADIOMETER AMERICA, INC. ABL 735 ANALYZER 11/24/1999
K935121 RADIOMETER AMERICA, INC. ABL SYSTEM 620 05/27/1994
K954612 RADIOMETER AMERICA, INC. ABL SYSTEM 625, 615, 605 11/09/1995
K844295 RADIOMETER AMERICA, INC. ABL300 ACID BASE LABORATORY 12/10/1984
K860057 RADIOMETER AMERICA, INC. ABL330 ACID BASE LABORATORY 03/05/1986
K935655 RADIOMETER AMERICA, INC. ABL5 BLOOD GAS SYSTEM 05/27/1994
K943882 RADIOMETER AMERICA, INC. ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM 03/10/1995
K922922 RADIOMETER AMERICA, INC. ABL50 BLOOD GAS SYSTEM 08/28/1992
K895181 RADIOMETER AMERICA, INC. ABL500 BLOOD GAS SYSTEM 10/06/1989
K914166 RADIOMETER AMERICA, INC. ABL505 BLOOD GAS & ELECTROLYTE SYSTEM 01/28/1992
K904513 RADIOMETER AMERICA, INC. ABL510 BLOOD GAS SYSTEM 12/13/1990
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
K842519 RNA MEDICAL CORP. BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 08/17/1984
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
K823750 SHABAN MFG. CO. CLEANING AGENT 01/14/1983
K841609 SHABAN MFG. CO. COMPONENTS FOR PARTIAL PRESSURE ELEE 05/25/1984
K844781 SHABAN MFG. CO. MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB 02/01/1985
K840468 SHABAN MFG. CO. PARTIAL PRESS. ELECTRODE MEASUREMENT 03/30/1984
K833534 SHABAN MFG. CO. PARTIAL PRESSURE ELECTRODE MEASUREMENT 12/29/1983
K833536 SHABAN MFG. CO. PARTIAL PRESSURE ELECTRODE MEASUREMENT 12/29/1983
K122539 SIEMENS HEALTHCARE DIAGNOSTICS MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM 04/19/2013
K882941 SWISCO, INC. BLOOD GAS MIXTURE 09/09/1988
K771822 TECHNICON INSTRUMENTS CORP. BG II ANALYZER 10/19/1977
K780716 TECHNICON INSTRUMENTS CORP. TECHNICON BGII ANALYZER 06/14/1978
K850360 TEXT TECH CORP. ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS 04/17/1985
K760229 THE LONDON CO. ACID BASE SYSTEM, RADIOMETER AUTOMATED 08/26/1976
K800224 THE LONDON CO. RADIOMETER ACID BASE LABORATORY-ABL-3 02/22/1980
K853840 THE PERKIN-ELMER CORP. LIFE WATCH RESPIRATORY MONITOR 12/09/1985
K984384 THERMO BIOANALYSIS CORP. 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 12/23/1998
K812552 TRANSIDYNE GENERAL CORP. COROMETRICS MEDICAL SYST. 220 PH ANALY. 09/23/1981
K800271 TRANSIDYNE GENERAL CORP. COROMETRICS MEDICAL SYSTEMS 220 PH SYS. 02/26/1980
K813517 UNITED DIAGNOSTICS, INC. BLOOD GAS ANALYSIS, STANDARDS CONTROLS 12/31/1981


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