Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
FDA product code CHL · 181 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1120
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-26 – 2026-04-10
CHL
2026-04-10
CHL
2025-05-02
i-STAT CG4+ cartridge with the i-STAT 1 System
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CHL
2024-12-13
ABL90 FLEX PLUS System
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2023-10-27
i-STAT CG8+ cartridge with the i-STAT 1 System
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CHL
2023-09-29
Stat Profile Prime Plus Analyzer System
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2023-09-15
i-STAT G3+ cartridge with the i-STAT 1 System
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CHL
2023-08-10
GEM Premier 7000 with IQM3
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CHL
2023-01-27
EasyStat 300
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CHL
2021-08-20
GEM Premier 5000
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CHL
2021-08-02
OPTI® B-Lac Cassette
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CHL
2020-06-05
epoc Blood Analysis System
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CHL
2020-04-09
i-STAT CG4+ Cartridge with the i-STAT 1 System
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CHL
2020-03-27
RAPIDPoint 500e Blood Gas System
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CHL
2020-01-24
Stat Profile Prime Plus Analyzer System
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CHL
2018-07-17
Stat Profile Prime Plus Analyzer System
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CHL
2017-12-29
GEM Premier 5000
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CHL
2016-12-14
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
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CHL
2016-11-04
ABL90 FLEX PLUS
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CHL
2016-07-15
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
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CHL
2013-09-17
ABL90 FLEX ANALYZER
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CHL
2013-08-22
OPTI CCA-TS2
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CHL
2013-07-31
ABL90 FLEX
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CHL
2013-05-07
ABL90 FLEX
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CHL
2013-04-19
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
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CHL
2012-11-16
ABL90 FLEX
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CHL
2012-10-26
ABL90 FLEX
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CHL
2012-05-14
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
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CHL
2012-03-19
ABL90 FLEX
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CHL
2011-08-29
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
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CHL
2011-07-19
ABL90
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CHL
2011-03-24
ABL835 FLEX ANALYZER WITH PLEURAL PH
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CHL
2011-01-07
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
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CHL
2010-12-10
ABL837 FLEX ANALYZER
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CHL
2008-07-31
ABL 80 CO-OX SYSTEM
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CHL
2007-06-25
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
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CHL
2006-09-15
GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
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CHL
2005-11-01
ABL80 FLEX ANALYZER
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CHL
2005-05-10
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
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CHL
2005-04-22
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
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CHL
2004-10-08
ABL800 FLEX
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CHL
2003-12-17
BAYER RAPIDLAB 1200 SYSTEM
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CHL
2002-12-20
STAT PROFILE PHOX PLUS L ANALYZER
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CHL
2002-11-22
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
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CHL
2002-07-25
STAT PROFILE PHOX PLUS C ANALYZER
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CHL
2002-07-16
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
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CHL
2002-06-10
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
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CHL
2002-02-28
STAT PROFILE PHOX ANALYZER
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CHL
2002-01-15
STAT PROFILE PHOX BASIC ANALYZER
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CHL
2001-08-20
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
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CHL
2001-08-20
STAT PROFILE PHOX PLUS L ANALYZER
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CHL
2000-12-19
BAYER RAPIDPOINT 400 SYSTEM
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CHL
2000-10-19
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
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CHL
2000-09-13
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
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CHL
2000-03-20
AVL OPTI R ANALYZER
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CHL
2000-02-01
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
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CHL
2000-01-10
CLINICAL BLOOD GAS MIXTURE
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CHL
2000-01-10
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
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CHL
1999-11-24
GEM PREMIER 3000
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CHL
1999-11-24
ABL 735 ANALYZER
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CHL
1999-01-29
AVL OMNI MODULAR ANALYZER
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CHL
1999-01-06
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
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CHL
1998-12-23
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
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CHL
1998-07-22
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
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CHL
1998-04-15
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
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CHL
1998-03-19
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
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CHL
1998-02-09
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
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CHL
1998-02-05
EASYBLOOD GAS ANALYZER
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CHL
1997-12-18
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
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CHL
1997-10-06
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
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CHL
1997-05-09
STAT PROFILE ULTRA M ANALYZER
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CHL
1996-11-29
AVL COMPACT 3 PH/BLOOD GAS ANALYZER
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CHL
1996-11-13
IL SYNTHESIS
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CHL
1996-06-28
GEM PREMIER PLUS MODEL 5500
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CHL
1996-06-25
CIBA CORNING 400 SYSTEM
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CHL
1996-06-24
CIBA CORNING 348 SYSTEM
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CHL
1996-04-26
AVL OPTI 1 PH/BLOOD GAS ANALYZER
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CHL
1996-02-14
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
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CHL
1995-12-04
SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM
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CHL
1995-11-30
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
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CHL
1995-11-20
MED-TECH CLINICAL BLOOD GAS
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CHL
1995-11-09
ABL SYSTEM 625, 615, 605
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CHL
1995-03-10
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
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CHL
1995-03-09
STAT PROFILE PLUS 10 ANALYZER
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CHL
1995-01-30
CIBA CORNING 8-- SERIES CO-OXIMETER
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CHL
1995-01-05
IRMA BLOOD ANALYSIS SYSTEM
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CHL
1994-12-29
STAT PROFILE ULTRA 11 ANALYZER
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CHL
1994-10-20
AVL OPTI PH/BLOOD GAS ANALYZER
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CHL
1994-08-24
AVL COMPACT 1 PH/BLOOD GAS ANALYZER
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CHL
1994-07-28
AVL COMPACT 2 PH/BLOOD GAS ANALYZER
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CHL
1994-05-27
ABL5 BLOOD GAS SYSTEM
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CHL
1994-05-27
ABL SYSTEM 620
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CHL
1994-05-10
I-STAT 200 PORTABLE CLINICAL ANALYZER
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CHL
1994-03-28
IL1430 BGELECTROLYTE ANALYZER
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CHL
1994-02-24
I-STAT TESTS FOR ACID-BASE PARAMETERS
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CHL
1994-02-03
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
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CHL
1994-01-03
860 MEASURMENT SYSTEM
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CHL
1993-10-14
AVL 9110PH ANALYZER
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CHL
1993-02-23
STAT PROFILE 9 ANALYZER
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CHL
1992-12-03
DMI BLOOD GAS ANALYZER/CARTRIDGE
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CHL
1992-11-10
STATPAL II BLOOD GAS ANALYSIS SYSTEM
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