JGS · Class II · 21 CFR 862.1665

FDA Product Code JGS: Electrode, Ion Specific, Sodium

Leading manufacturers include Nova Biomedical Corp., Medica Corp. and Instrumentation Laboratory CO.

162
Total
162
Cleared
95d
Avg days
1977
Since
162 devices
73–96 of 162
Cleared Jul 17, 1992
NOVA 14 NA/K/CL/GLU/BUN ANALYZER
K922215
Nova Biomedical Corp.
Chemistry · 84d
Cleared Jan 15, 1992
NOVA 4 NA/K/C1/TCO2/LI ANALYZER
K915176
Nova Biomedical Corp.
Chemistry · 61d
Cleared Dec 04, 1991
EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER
K914810
Medica Corp.
Chemistry · 40d
Cleared Sep 30, 1991
MEDISENSOR 2001
K903564
Medtest Systems, Inc.
Chemistry · 419d
Cleared Jul 17, 1991
NOVA 12 ANALYZER
K912560
Nova Biomedical Corp.
Chemistry · 36d
Cleared Jul 17, 1991
ISE/NA+
K912648
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jul 01, 1991
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
K912387
I-Stat Corp.
Chemistry · 61d
Cleared Jul 01, 1991
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
K912559
Nova Biomedical Corp.
Chemistry · 20d
Cleared Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Apr 03, 1991
GEM-PREMIER SYSTEM
K910305
Mallinckrodt Sensor Systems, Inc.
Chemistry · 69d
Cleared Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
K910554
Baxter Healthcare Corp
Chemistry · 34d
Cleared Mar 05, 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
K905264
Nova Biomedical Corp.
Chemistry · 104d
Cleared Jan 15, 1991
TECHLYTE ELECTROLYTE ANALYZER
K905600
Technalysis, Inc.
Chemistry · 32d
Cleared Oct 12, 1990
SECONDARY CALIBRATORS
K904335
Bionostics, Inc.
Chemistry · 22d
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188
Abbott Laboratories
Chemistry · 53d
Cleared Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042
Fresenius USA, Inc.
Chemistry · 147d
Cleared Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040
Fresenius USA, Inc.
Chemistry · 135d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526
Baxter Healthcare Corp
Chemistry · 50d
Cleared Dec 12, 1989
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936
Medica Corp.
Chemistry · 62d
Cleared Oct 31, 1989
EOS CHEMISTRY ANALYZER
K894035
Eos Technology Corp.
Chemistry · 147d
Cleared Oct 25, 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672
Technicon Instruments Corp.
Chemistry · 35d
Cleared Oct 16, 1989
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
K894914
I-Stat Corp.
Chemistry · 75d
Cleared Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218
Nova Biomedical Corp.
Chemistry · 80d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500
Ciba Corning Diagnostics Corp.
Chemistry · 98d