Electrode, Ion-Specific, Chloride

FDA product code CGZ · 38 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1170
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-06-15 – 2018-10-30

CGZ 2018-10-30

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K number K182072

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CGZ 2017-10-24

Alinity c ICT Sample Diluent

Applicant Abbott Laboratories

K number K170320

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CGZ 2016-12-16

VITROS Chemistry Products Cl- Slides

Applicant Ortho Clinical Diagnostics

K number K162020

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CGZ 2008-08-21

VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

Applicant Ortho-Clinical Diagnostics, Inc.

K number K082099

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CGZ 2008-04-14

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112

Applicant Wallac OY

K number K070889

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CGZ 2007-09-04

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER

Applicant Thermo Fisher Scientific

K number K070531

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CGZ 2006-02-16

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

Applicant Roche Diagnostics Corp.

K number K060108

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CGZ 2005-09-29

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

Applicant Osmetech, Inc.

K number K052027

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CGZ 2002-02-04

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

Applicant Phoenix Diagnostics, Inc.

K number K020148

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CGZ 2001-12-18

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

Applicant Phoenix Diagnostics, Inc.

K number K013451

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CGZ 2001-02-14

DELFIA NEONATAL IRT KIT, MODEL A005-110

Applicant Wallac OY

K number K003664

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CGZ 2001-02-12

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

Applicant Wallac OY

K number K003668

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CGZ 2000-06-09

DELFIA NEONATAL IRT KIT

Applicant Wallac OY

K number K993697

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CGZ 2000-05-15

EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER

Applicant Medica Corp.

K number K000926

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CGZ 1999-07-30

ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03

Applicant A.P. Total Care, Inc.

K number K991870

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CGZ 1998-05-01

IRMA BLOOD ANALYSIS SYSTEM

Applicant Diametrics Medical, Inc.

K number K981270

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CGZ 1998-04-21

ILAB 600 CLINICAL CHEMISTRY SYSTEM

Applicant Instrumentation Laboratory CO

K number K980757

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CGZ 1998-04-01

AEROSET SYSTEM

Applicant Abbott Laboratories

K number K980367

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CGZ 1997-12-03

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

Applicant Sendx Medical, Inc.

K number K973742

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CGZ 1997-06-16

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS

Applicant Alko Diagnostic Corp.

K number K972004

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CGZ 1997-03-03

SYNERMED ISE REAGENTS

Applicant Synermed, Inc.

K number K962479

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CGZ 1996-11-29

CAPILLARY ADAPTOR ACCESSORY

Applicant Medica Corp.

K number K963992

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CGZ 1996-10-24

ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS

Applicant Alko Diagnostic Corp.

K number K963734

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CGZ 1995-09-06

HICHEM ISEKCI SOLUTION KIT 70010

Applicant Hichem Diagnostics

K number K953862

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CGZ 1995-09-06

HICHEM ISE INTDERNAL REFERENCE KIT 70009

Applicant Hichem Diagnostics

K number K953861

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CGZ 1995-09-06

HICHEM ISE DILUENT KIT 70008

Applicant Hichem Diagnostics

K number K953860

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CGZ 1994-08-01

MODEL 644 SWEAT DILUENT

Applicant Ciba Corning Diagnostics Corp.

K number K935228

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CGZ 1992-11-06

NOVA 13 ANALYZER, MODIFICATION

Applicant Nova Biomedical Corp.

K number K924864

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CGZ 1991-09-11

NOVA 13 ANALYZER

Applicant Nova Biomedical Corp.

K number K912561

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CGZ 1991-07-17

ISE/CI-

Applicant Boehringer Mannheim Corp.

K number K912647

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CGZ 1990-05-15

ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER

Applicant Abbott Laboratories

K number K900887

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CGZ 1989-08-11

OLYMPUS ISE MODULE FOR AU5000

Applicant Olympus Corp.

K number K893628

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CGZ 1989-02-03

OLYMPUS ISE MODULE

Applicant Olympus Corp.

K number K885193

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CGZ 1988-05-24

WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER

Applicant Wescor, Inc.

K number K863395

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CGZ 1986-05-27

SODIUM, POTASSIUM AND CHLORIDE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861669

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CGZ 1986-04-07

ION-SPECIFIC ELECTRODE, CHLORIDE

Applicant Em Diagnostic Systems, Inc.

K number K860668

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CGZ 1984-12-10

ISE REAGENTS FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K844021

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CGZ 1979-06-15

NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER

Applicant Nova Corp.

K number K790653

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