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Panels › Clinical Chemistry › Product code CHL · Class 2

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

Regulation 862.1120

1510(k)s in 12 months (188 all time)
33recalls in 12 months (185 all time)
173recalls that name a 510(k)
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Top companies in CHL

Decided510(k)Device and applicantCode
Jul 25, 2002K021713STAT PROFILE PHOX PLUS C ANALYZER
Nova Biomedical Corp.
CHL
Jul 16, 2002K021515EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
Medica Corp.
CHL
Jun 10, 2002K020297STAT PROFILE CRITICAL CARE XPRESS ANALYZER
Nova Biomedical Corp.
CHL
Feb 28, 2002K014295STAT PROFILE PHOX ANALYZER
Nova Biomedical Corp.
CHL
Jan 15, 2002K013729STAT PROFILE PHOX BASIC ANALYZER
Nova Biomedical Corp.
CHL
Aug 20, 2001K012478MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
I-Stat Corp.
CHL
Aug 20, 2001K012058STAT PROFILE PHOX PLUS L ANALYZER
Nova Biomedical Corp.
CHL
Dec 19, 2000K002738BAYER RAPIDPOINT 400 SYSTEM
Bayer Corp.
CHL
Oct 19, 2000K002613MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
Nova Biomedical Corp.
CHL
Sep 13, 2000K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
Radiometer Medical A/S, DK
CHL
Mar 20, 2000K000103AVL OPTI R ANALYZER
Avl Scientific Corp.
CHL
Feb 1, 2000K994346ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Sendx Medical, Inc.
CHL
Jan 10, 2000K993789CLINICAL BLOOD GAS MIXTURE
General Air Service and Supply
CHL
Jan 10, 2000K992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
Radiometer America, Inc.
CHL
Nov 24, 1999K992834GEM PREMIER 3000
Instrumentation Laboratory CO
CHL
Nov 24, 1999K991417ABL 735 ANALYZER
Radiometer America, Inc.
CHL
Jan 29, 1999K990092AVL OMNI MODULAR ANALYZER
Avl Scientific Corp.
CHL
Jan 6, 1999K982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
Radiometer America, Inc.
CHL
Dec 23, 1998K9843846.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
Thermo Bioanalysis Corp.
CHL
Jul 22, 1998K982277MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
Nova Biomedical Corp.
CHL
Apr 15, 1998K980991NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
Nova Biomedical Corp.
CHL
Mar 19, 1998K980523IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
Diametrics Medical, Inc.
CHL
Feb 9, 1998K980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Radiometer America, Inc.
CHL
Feb 5, 1998K974526EASYBLOOD GAS ANALYZER
Medica Corp.
CHL
Dec 18, 1997K974396IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
Diametrics Medical, Inc.
CHL
Oct 6, 1997K973367ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
Radiometer America, Inc.
CHL
May 9, 1997K970710STAT PROFILE ULTRA M ANALYZER
Nova Biomedical Corp.
CHL
Nov 29, 1996K963964AVL COMPACT 3 PH/BLOOD GAS ANALYZER
Avl Scientific Corp.
CHL
Nov 13, 1996K963800IL SYNTHESIS
Instrumentation Laboratory CO
CHL
Jun 28, 1996K961335GEM PREMIER PLUS MODEL 5500
Mallinckrodt Sensor Systems, Inc.
CHL
Jun 25, 1996K961657CIBA CORNING 400 SYSTEM
Ciba Corning Diagnostics Corp.
CHL
Jun 24, 1996K962021CIBA CORNING 348 SYSTEM
Ciba Corning Diagnostics Corp.
CHL
Apr 26, 1996K961161AVL OPTI 1 PH/BLOOD GAS ANALYZER
Avl Scientific Corp.
CHL
Feb 14, 1996K955793IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
Instrumentation Laboratory CO
CHL
Dec 4, 1995K954482SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM
Cirrus Medical,Inc.
CHL
Nov 30, 1995K954711STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
Nova Biomedical Corp.
CHL
Nov 20, 1995K953935MED-TECH CLINICAL BLOOD GAS
Medical Technical Gases Inc..
CHL
Nov 9, 1995K954612ABL SYSTEM 625, 615, 605
Radiometer America, Inc.
CHL
Mar 10, 1995K943882ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
Radiometer America, Inc.
CHL
Mar 9, 1995K936203STAT PROFILE PLUS 10 ANALYZER
Nova Biomedical Corp.
CHL
Jan 30, 1995K946206CIBA CORNING 8-- SERIES CO-OXIMETER
Ciba Corning Diagnostics Corp.
CHL
Jan 5, 1995K945240IRMA BLOOD ANALYSIS SYSTEM
Diametrics Medical, Inc.
CHL
Dec 29, 1994K943643STAT PROFILE ULTRA 11 ANALYZER
Nova Biomedical Corp.
CHL
Oct 20, 1994K944089AVL OPTI PH/BLOOD GAS ANALYZER
Avl Scientific Corp.
CHL
Aug 24, 1994K943570AVL COMPACT 1 PH/BLOOD GAS ANALYZER
Avl Scientific Corp.
CHL
Jul 28, 1994K942616AVL COMPACT 2 PH/BLOOD GAS ANALYZER
Avl Scientific Corp.
CHL
May 27, 1994K935655ABL5 BLOOD GAS SYSTEM
Radiometer America, Inc.
CHL
May 27, 1994K935121ABL SYSTEM 620
Radiometer America, Inc.
CHL
May 10, 1994K940918I-STAT 200 PORTABLE CLINICAL ANALYZER
I-Stat Corp.
CHL
Mar 28, 1994K935069IL1430 BGELECTROLYTE ANALYZER
Instrumentation Laboratory CO
CHL

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