Product Code: CHL FDA class 2 21 CFR 862.1120

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Clinical Chemistry

The Electrode Measurement, Blood-Gases (pCO2, pO2) and Blood pH test system (product code CHL) is an in-vitro diagnostic device used in clinical chemistry to measure partial pressures of carbon dioxide and oxygen as well as blood pH using electrochemical electrodes, providing critical information for respiratory and metabolic status assessment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1120 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

188

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CHL
Device Class: FDA class 2
Regulation Number: 862.1120
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 188 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252207	ABL90 FLEX PLUS System, safeCLINITUBES	Apr 10, 2026	Substantially Equivalent	Radiometer Medicals Aps
K244014	i-STAT CG4+ cartridge with the i-STAT 1 System	May 02, 2025	Substantially Equivalent	Abbott Point of Care, Inc.
K240998	ABL90 FLEX PLUS System	Dec 13, 2024	Substantially Equivalent	Radiometer Medicals Aps
K230285	i-STAT CG8+ cartridge with the i-STAT 1 System	Oct 27, 2023	Substantially Equivalent	Abbott Point of Care, Inc.
K221900	Stat Profile Prime Plus Analyzer System	Sep 29, 2023	Substantially Equivalent	Nova Biomedical Corporation
K223857	i-STAT G3+ cartridge with the i-STAT 1 System	Sep 15, 2023	Substantially Equivalent	Abbott Point of Care, Inc.
K223608	GEM Premier 7000 with IQM3	Aug 10, 2023	Substantially Equivalent	Instrumentation Laboratory Company
K211559	EasyStat 300	Jan 27, 2023	Substantially Equivalent	Medica Corporation
K203790	GEM Premier 5000	Aug 20, 2021	Substantially Equivalent	Instrumentation Laboratory CO
K200986	OPTI® B-Lac Cassette	Aug 02, 2021	Substantially Equivalent	Opti Medical Systems, Inc.
K200107	epoc Blood Analysis System	Jun 05, 2020	Substantially Equivalent	Epocal, Inc.
K200492	i-STAT CG4+ Cartridge with the i-STAT 1 System	Apr 09, 2020	Substantially Equivalent	Abbott Point of Care, Inc.
K192240	RAPIDPoint 500e Blood Gas System	Mar 27, 2020	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K193246	Stat Profile Prime Plus Analyzer System	Jan 24, 2020	Substantially Equivalent	Nova Biomedical Corporation
K173797	Stat Profile Prime Plus Analyzer System	Jul 17, 2018	Substantially Equivalent	Nova Biomedical Corporation
K173403	GEM Premier 5000	Dec 29, 2017	Substantially Equivalent	Instrumentation Laboratory CO
K160412	GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)	Dec 14, 2016	Substantially Equivalent	Instrumentation Laboratory CO
K160153	ABL90 FLEX PLUS	Nov 04, 2016	Substantially Equivalent	Radiometer Medical Aps
K151978	EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control	Jul 15, 2016	Substantially Equivalent	Edan Instruments, Inc.
K151982	Stat Profile Prime ABG Analyzer System	Sep 10, 2015	Substantially Equivalent	Nova Biomedical Corporation
K151856	ABL80 FLEX CO-OX with AQURE connectivity	Aug 06, 2015	Substantially Equivalent	Sendx Medical, Inc.
K142898	ABL800 FLEX with AQURE connectivity	Jun 17, 2015	Substantially Equivalent	Radiometer Medical Aps
K141907	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	May 29, 2015	Substantially Equivalent	Nova Biomedical Corporation
K142220	Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)	Oct 17, 2014	Substantially Equivalent	Nova Biomedical Corporation
K131703	NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM	Mar 25, 2014	Substantially Equivalent	Nova Biomedical Corporation
K133407	GEM PREMIER 4000	Jan 13, 2014	Substantially Equivalent	Instrumentation Laboratory CO
K131988	ABL90 FLEX ANALYZER	Sep 17, 2013	Substantially Equivalent	Radiometer Medical Aps
K131126	OPTI CCA-TS2	Aug 22, 2013	Substantially Equivalent	Opti Medical Systems, Inc.
K130144	ABL90 FLEX	Jul 31, 2013	Substantially Equivalent	Radiometer Medical Aps
K123748	ABL90 FLEX	May 07, 2013	Substantially Equivalent	Radiometer Medical Aps
K122539	MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM	Apr 19, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics
K122729	ABL90 FLEX	Nov 16, 2012	Substantially Equivalent	Radiometer Medical Aps
K122642	ABL90 FLEX	Oct 26, 2012	Substantially Equivalent	Radiometer Medical Aps
K111188	COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B	May 14, 2012	Substantially Equivalent	Roche Diagnostics
K120197	ABL90 FLEX	Mar 19, 2012	Substantially Equivalent	Radiometer Medical Aps
K110648	NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM	Aug 29, 2011	Substantially Equivalent	Nova Biomedical Corporation
K111897	ABL90	Jul 19, 2011	Substantially Equivalent	Radiometer Medical Aps
K110416	ABL835 FLEX ANALYZER WITH PLEURAL PH	Mar 24, 2011	Substantially Equivalent	Radiometer Medical Aps
K093280	OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561	Jan 07, 2011	Substantially Equivalent	Opti Medical Systems, Inc.
K100777	ABL837 FLEX ANALYZER	Dec 10, 2010	Substantially Equivalent	Radiometer Medical Aps
K080370	ABL 80 CO-OX SYSTEM	Jul 31, 2008	Substantially Equivalent	Sendx Medical, Inc.
K063376	EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER	Jun 25, 2007	Substantially Equivalent	Medica Corp.
K061974	GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT	Sep 15, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K051804	ABL80 FLEX ANALYZER	Nov 01, 2005	Substantially Equivalent	Sendx Medical, Inc.
K043218	ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX	May 10, 2005	Substantially Equivalent	Radiometer Medical Aps
K050423	OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)	Apr 22, 2005	Substantially Equivalent	Roche Diagnostics
K041874	ABL800 FLEX	Oct 08, 2004	Substantially Equivalent	Radiometer Medical Aps
K031560	BAYER RAPIDLAB 1200 SYSTEM	Dec 17, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K023567	STAT PROFILE PHOX PLUS L ANALYZER	Dec 20, 2002	Substantially Equivalent	Nova Biomedical Corp.
K022746	STAT PROFILE CRITICAL CARE XPRESS ANALYZER	Nov 22, 2002	Substantially Equivalent	Nova Biomedical Corp.
K021713	STAT PROFILE PHOX PLUS C ANALYZER	Jul 25, 2002	Substantially Equivalent	Nova Biomedical Corp.
K021515	EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER	Jul 16, 2002	Substantially Equivalent	Medica Corp.
K020297	STAT PROFILE CRITICAL CARE XPRESS ANALYZER	Jun 10, 2002	Substantially Equivalent	Nova Biomedical Corp.
K014295	STAT PROFILE PHOX ANALYZER	Feb 28, 2002	Substantially Equivalent	Nova Biomedical Corp.
K013729	STAT PROFILE PHOX BASIC ANALYZER	Jan 15, 2002	Substantially Equivalent	Nova Biomedical Corp.
K012478	MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER	Aug 20, 2001	Substantially Equivalent	I-Stat Corp.
K012058	STAT PROFILE PHOX PLUS L ANALYZER	Aug 20, 2001	Substantially Equivalent	Nova Biomedical Corp.
K002738	BAYER RAPIDPOINT 400 SYSTEM	Dec 19, 2000	Substantially Equivalent	Bayer Corp.
K002613	MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER	Oct 19, 2000	Substantially Equivalent	Nova Biomedical Corp.
K002290	ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)	Sep 13, 2000	Substantially Equivalent	Radiometer Medical A/S
K000103	AVL OPTI R ANALYZER	Mar 20, 2000	Substantially Equivalent	Avl Scientific Corp.
K994346	ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM	Feb 01, 2000	Substantially Equivalent	Sendx Medical, Inc.
K993789	CLINICAL BLOOD GAS MIXTURE	Jan 10, 2000	Substantially Equivalent	General Air Service and Supply
K992859	ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE	Jan 10, 2000	Substantially Equivalent	Radiometer America, Inc.
K992834	GEM PREMIER 3000	Nov 24, 1999	Substantially Equivalent	Instrumentation Laboratory CO
K991417	ABL 735 ANALYZER	Nov 24, 1999	Substantially Equivalent	Radiometer America, Inc.
K990092	AVL OMNI MODULAR ANALYZER	Jan 29, 1999	Substantially Equivalent	Avl Scientific Corp.
K982928	NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM	Jan 06, 1999	Substantially Equivalent	Radiometer America, Inc.
K984384	6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497	Dec 23, 1998	Substantially Equivalent	Thermo Bioanalysis Corp.
K982277	MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)	Jul 22, 1998	Substantially Equivalent	Nova Biomedical Corp.
K980991	NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER	Apr 15, 1998	Substantially Equivalent	Nova Biomedical Corp.
K980523	IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE	Mar 19, 1998	Substantially Equivalent	Diametrics Medical, Inc.
K980130	ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM	Feb 09, 1998	Substantially Equivalent	Radiometer America, Inc.
K974526	EASYBLOOD GAS ANALYZER	Feb 05, 1998	Substantially Equivalent	Medica Corp.
K974396	IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE	Dec 18, 1997	Substantially Equivalent	Diametrics Medical, Inc.
K973367	ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM	Oct 06, 1997	Substantially Equivalent	Radiometer America, Inc.
K970710	STAT PROFILE ULTRA M ANALYZER	May 09, 1997	Substantially Equivalent	Nova Biomedical Corp.
K963964	AVL COMPACT 3 PH/BLOOD GAS ANALYZER	Nov 29, 1996	Substantially Equivalent	Avl Scientific Corp.
K963800	IL SYNTHESIS	Nov 13, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K961335	GEM PREMIER PLUS MODEL 5500	Jun 28, 1996	Substantially Equivalent	Mallinckrodt Sensor Systems, Inc.
K961657	CIBA CORNING 400 SYSTEM	Jun 25, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K962021	CIBA CORNING 348 SYSTEM	Jun 24, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K961161	AVL OPTI 1 PH/BLOOD GAS ANALYZER	Apr 26, 1996	Substantially Equivalent	Avl Scientific Corp.
K955793	IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM	Feb 14, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K954482	SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM	Dec 04, 1995	Substantially Equivalent	Cirrus Medical,Inc.
K954711	STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)	Nov 30, 1995	Substantially Equivalent	Nova Biomedical Corp.
K953935	MED-TECH CLINICAL BLOOD GAS	Nov 20, 1995	Substantially Equivalent	Medical Technical Gases Inc..
K954612	ABL SYSTEM 625, 615, 605	Nov 09, 1995	Substantially Equivalent	Radiometer America, Inc.
K943882	ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM	Mar 10, 1995	Substantially Equivalent	Radiometer America, Inc.
K936203	STAT PROFILE PLUS 10 ANALYZER	Mar 09, 1995	Substantially Equivalent	Nova Biomedical Corp.
K946206	CIBA CORNING 8-- SERIES CO-OXIMETER	Jan 30, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K945240	IRMA BLOOD ANALYSIS SYSTEM	Jan 05, 1995	Substantially Equivalent	Diametrics Medical, Inc.
K943643	STAT PROFILE ULTRA 11 ANALYZER	Dec 29, 1994	Substantially Equivalent	Nova Biomedical Corp.
K944089	AVL OPTI PH/BLOOD GAS ANALYZER	Oct 20, 1994	Substantially Equivalent	Avl Scientific Corp.
K943570	AVL COMPACT 1 PH/BLOOD GAS ANALYZER	Aug 24, 1994	Substantially Equivalent	Avl Scientific Corp.
K942616	AVL COMPACT 2 PH/BLOOD GAS ANALYZER	Jul 28, 1994	Substantially Equivalent	Avl Scientific Corp.
K935655	ABL5 BLOOD GAS SYSTEM	May 27, 1994	Substantially Equivalent	Radiometer America, Inc.
K935121	ABL SYSTEM 620	May 27, 1994	Substantially Equivalent	Radiometer America, Inc.
K940918	I-STAT 200 PORTABLE CLINICAL ANALYZER	May 10, 1994	Substantially Equivalent	I-Stat Corp.
K935069	IL1430 BGELECTROLYTE ANALYZER	Mar 28, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K936081	I-STAT TESTS FOR ACID-BASE PARAMETERS	Feb 24, 1994	Substantially Equivalent	I-Stat Corp.
K935830	CIBA CORNING 248 PH/BLOOD GAS ANALYZER	Feb 03, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K934907	860 MEASURMENT SYSTEM	Jan 03, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K932642	AVL 9110PH ANALYZER	Oct 14, 1993	Substantially Equivalent	Avl Scientific Corp.
K924497	STAT PROFILE 9 ANALYZER	Feb 23, 1993	Substantially Equivalent	Nova Biomedical Corp.
K924758	DMI BLOOD GAS ANALYZER/CARTRIDGE	Dec 03, 1992	Substantially Equivalent	Diamond Medical, Inc.
K922631	STATPAL II BLOOD GAS ANALYSIS SYSTEM	Nov 10, 1992	Substantially Equivalent	Ppg Industries, Inc.
K922922	ABL50 BLOOD GAS SYSTEM	Aug 28, 1992	Substantially Equivalent	Radiometer America, Inc.
K914166	ABL505 BLOOD GAS & ELECTROLYTE SYSTEM	Jan 28, 1992	Substantially Equivalent	Radiometer America, Inc.
K915087	DMI BLOD GAS ANALYZER/CARTRIDGE	Jan 08, 1992	Substantially Equivalent	Diamond Medical, Inc.
K914560	STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL	Nov 29, 1991	Substantially Equivalent	Ppg Industries, Inc.
K913927	IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST	Oct 11, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K903965	STATPAL BLOOD GAS MONITORING SYSTEM	Dec 26, 1990	Substantially Equivalent	Ppg Industries, Inc.
K904513	ABL510 BLOOD GAS SYSTEM	Dec 13, 1990	Substantially Equivalent	Radiometer America, Inc.
K904188	CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER	Sep 27, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K902267	BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS	Jun 12, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K895317	AVL MODEL 995HB PH/BLOOD GAS ANALYZER	Feb 01, 1990	Substantially Equivalent	Avl Scientific Corp.
K895181	ABL500 BLOOD GAS SYSTEM	Oct 06, 1989	Substantially Equivalent	Radiometer America, Inc.
K890827	IL1400, BGELECTROLYTE ANALYZER	Jun 20, 1989	Substantially Equivalent	Instrumentation Laboratory CO
K891578	AVL MODEL 987 ELECTROLYTE ANALYZER	May 22, 1989	Substantially Equivalent	Avl Scientific Corp.
K884267	ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS	May 04, 1989	Substantially Equivalent	Alko Diagnostic Corp.
K884143	NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER	Dec 02, 1988	Substantially Equivalent	Nova Biomedical Corp.
K882941	BLOOD GAS MIXTURE	Sep 09, 1988	Substantially Equivalent	Swisco, Inc.
K882209	MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES	Aug 02, 1988	Substantially Equivalent	Linde Div. Union Carbide Corp.
K881188	BLOOD PH CAPILLARY TUBES, HEPARIN	Jul 08, 1988	Substantially Equivalent	Helps Products, Inc.
K873577	GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK	Apr 28, 1988	Substantially Equivalent	Diamond Sensor Systems
K871397	ANALYZER: NOVA STAT PROFILE 3 ANALYZER	Jun 03, 1987	Substantially Equivalent	Nova Biomedical Corp.
K865036	CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM	Mar 06, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K864445	STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL	Feb 04, 1987	Substantially Equivalent	Nova Biomedical Corp.
K863880	BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.	Nov 24, 1986	Substantially Equivalent	D.R.G. Scientific Industries
K860057	ABL330 ACID BASE LABORATORY	Mar 05, 1986	Substantially Equivalent	Radiometer America, Inc.
K853840	LIFE WATCH RESPIRATORY MONITOR	Dec 09, 1985	Substantially Equivalent	The Perkin-Elmer Corp.
K854608	ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.	Dec 05, 1985	Substantially Equivalent	Nova Biomedical Corp.
K853405	ELECTROLYTE ANALYZER SERA-252	Dec 04, 1985	Substantially Equivalent	Horiba Instruments, Inc.
K852790	ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT	Nov 12, 1985	Substantially Equivalent	Nova Biomedical Corp.
K852676	IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS	Jul 22, 1985	Substantially Equivalent	Allied Instrumentation Laboratory
K850360	ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS	Apr 17, 1985	Substantially Equivalent	Text Tech Corp.
K844781	MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB	Feb 01, 1985	Substantially Equivalent	Shaban Mfg. Co.
K844295	ABL300 ACID BASE LABORATORY	Dec 10, 1984	Substantially Equivalent	Radiometer America, Inc.
K842519	BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302	Aug 17, 1984	Substantially Equivalent	Rna Medical Corp.
K841609	COMPONENTS FOR PARTIAL PRESSURE ELEE	May 25, 1984	Substantially Equivalent	Shaban Mfg. Co.
K840843	POTASSIUM CHLORIDE TABLETS	Apr 17, 1984	Substantially Equivalent	Bionostics, Inc.
K840468	PARTIAL PRESS. ELECTRODE MEASUREMENT	Mar 30, 1984	Substantially Equivalent	Shaban Mfg. Co.
K840300	FLUSH SOLUTION CONCENTRATE-BLOOD GAS	Mar 23, 1984	Substantially Equivalent	Bionostics, Inc.
K834601	AVL MODEL 945 BLOOD GAS SYSTEM	Mar 09, 1984	Substantially Equivalent	Avl Scientific Corp.
K833536	PARTIAL PRESSURE ELECTRODE MEASUREMENT	Dec 29, 1983	Substantially Equivalent	Shaban Mfg. Co.
K833534	PARTIAL PRESSURE ELECTRODE MEASUREMENT	Dec 29, 1983	Substantially Equivalent	Shaban Mfg. Co.
K832981	ELECTRODES FOR BLOOD GAS ANALYZERS	Oct 28, 1983	Substantially Equivalent	Analytical Products, Inc.
K832779	REFEREE BLOOD GAS ANALYZER-ELECTRODES	Oct 14, 1983	Substantially Equivalent	Analytical Products, Inc.
K831379	MODEL 947 VIDEO BLOOD GAS SYS	Jul 28, 1983	Substantially Equivalent	Avl Scientific Corp.
K831025	ELECTROLYLE CARBON DIOXIDE ELECTRODES	Jun 16, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831024	ELECTROLYTE PO2 FOR OXYGEN ELECTRODES	Jun 16, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831021	CALIBRATING SOLUTION FOR ABL-1 & 2	Jun 16, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831019	PH 6.838 REF. BUFFER	Jun 16, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831018	CALIBRATING SOLUTION FOR ABL-1 & 2	Jun 16, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831023	REFERENCE BUFFER PH 7.382	Jun 15, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831013	DIAGNOSTICS PO 2 ELECTROLYTE	Jun 08, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831012	DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON	Jun 08, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831015	DIAGNOSTICS PH ELECTRODE CLEANING SOLUT	May 25, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831020	FLUSH SOLUTION CONCENTRATE	May 09, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831017	BUFFER PACK FOR ABL-1 & ABL-2	May 09, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831016	BATH CLEAR	May 05, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K831010	DIAGNOSTICS PO2 ELECTRODE CLEANER	May 05, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K823750	CLEANING AGENT	Jan 14, 1983	Substantially Equivalent	Shaban Mfg. Co.
K823570	CORNING 170 PH/BLOOD GAS ANALYZER	Dec 28, 1982	Substantially Equivalent	Corning Medical & Scientific
K821483	IL 1302 PH BLOOD GAS ANALYZER	Jun 10, 1982	Substantially Equivalent	Instrumentation Laboratory CO
K820744	IL MODEL 1301, PH BLOOD GAS SYSTEM	Apr 15, 1982	Substantially Equivalent	Instrumentation Laboratory CO
K820597	158 BLOOD GAS ANALYZER	Mar 26, 1982	Substantially Equivalent	Corning Medical & Scientific
K813517	BLOOD GAS ANALYSIS, STANDARDS CONTROLS	Dec 31, 1981	Substantially Equivalent	United Diagnostics, Inc.
K812090	LORENZ BLOOD GAS ANALYZER	Nov 10, 1981	Substantially Equivalent	Lorenz Instruments
K812623	CLEANING SOLUTION FOR RADIOMETER OSM2	Nov 02, 1981	Substantially Equivalent	Fisher Scientific Co., LLC
K812552	COROMETRICS MEDICAL SYST. 220 PH ANALY.	Sep 23, 1981	Substantially Equivalent	Transidyne General Corp.
K810724	CORNING 178 BLOOD GAS ANALYZER	Mar 31, 1981	Substantially Equivalent	Corning Medical & Scientific
K810308	ARTERIAL MICROCOLLECTION SET	Feb 19, 1981	Substantially Equivalent	American Dade
K800757	IL MODEL 1303 PH/BLOOD GAS ANALYZER	Apr 21, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K800271	COROMETRICS MEDICAL SYSTEMS 220 PH SYS.	Feb 26, 1980	Substantially Equivalent	Transidyne General Corp.
K800224	RADIOMETER ACID BASE LABORATORY-ABL-3	Feb 22, 1980	Substantially Equivalent	The London Co.
K792230	AVL MODEL 940 AUTOMATIC PH/BLOOD GAS	Dec 31, 1979	Substantially Equivalent	Gauntlet Technology Corp.
K781968	BLOOD GAS SYSTEM MODEL 168	Jan 03, 1979	Substantially Equivalent	Corning Medical & Scientific
K780716	TECHNICON BGII ANALYZER	Jun 14, 1978	Substantially Equivalent	Technicon Instruments Corp.
K772307	PCO 2 ELECTROLYTE	Dec 22, 1977	Substantially Equivalent	Fisher Scientific Co., LLC
K771822	BG II ANALYZER	Oct 19, 1977	Substantially Equivalent	Technicon Instruments Corp.
K771147	AVL BLOOD GAS INSTRUMENT MODEL 939	Sep 15, 1977	Substantially Equivalent	Jones Medical Instrument Co.
K771253	HEMOX-ANALYZER	Aug 25, 1977	Substantially Equivalent	3M Company
K770736	MONITOR, PATIENT, MODEL PM-20N	Jun 02, 1977	Substantially Equivalent	Cavitron Corp.
K760969	PH/BLOOD GAS SYSTEM	Jan 12, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K760748	REAGENTS FOR BLOOD GAS INSTRUMENTATION	Nov 01, 1976	Substantially Equivalent	Alko Scientific Co.
K760229	ACID BASE SYSTEM, RADIOMETER AUTOMATED	Aug 26, 1976	Substantially Equivalent	The London Co.