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
25–48 of 162
Cleared Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829
Medica Corp.
Chemistry · 296d
Cleared Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
K102959
Diamond Diagnostics, Inc.
Chemistry · 101d
Cleared Apr 06, 2010
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673
Medica Corp.
Chemistry · 28d
Cleared Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861
Ortho-Clinical Diagnostics, Inc.
Chemistry · 76d
Cleared Feb 06, 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462
Diamond Diagnostics, Inc.
Chemistry · 163d
Cleared Jun 30, 2008
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared May 07, 2008
PROLYTE ELECTROLYTE ANALYZER
K070104
Diamond Diagnostics, Inc.
Chemistry · 483d
Cleared Sep 27, 2006
EPOC BLOOD ANALYSIS SYSTEM
K061597
Epocal, Inc.
Chemistry · 111d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
K053110
I-Stat Corporation
Chemistry · 70d
Cleared Dec 14, 2005
TECO ISE REAGENT SET FOR CX SYSTEM
K052724
Teco Diagnostics
Chemistry · 76d
Cleared Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Oct 07, 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646
Pointe Scientific, Inc.,
Chemistry · 108d
Cleared Dec 27, 2004
GENCHEM ELECTROLYTE BUFFER
K040977
Genchem, Inc.
Chemistry · 257d
Cleared Dec 22, 2004
GENCHEM ISE ELECTROLYTE REFERENCE
K040971
Genchem, Inc.
Chemistry · 252d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364
Phoenix Diagnostics, Inc.
Chemistry · 120d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213
Beckman Coulter, Inc.
Chemistry · 26d
Cleared Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407
Medica Corp.
Chemistry · 179d
Cleared Oct 12, 2000
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
K002855
Biocare Corp.
Chemistry · 29d
Cleared Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761
Nova Biomedical Corp.
Chemistry · 59d
Cleared Apr 18, 2000
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
K001154
I-Stat Corp.
Chemistry · 8d
Cleared Apr 17, 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895
Nova Biomedical Corp.
Chemistry · 28d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE REFERENCE
K992842
Elan Holdings, Inc.
Chemistry · 94d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE BUFFER
K992844
Elan Holdings, Inc.
Chemistry · 94d