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
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 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 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 Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761
Nova Biomedical Corp.
Chemistry · 59d
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
Cleared Oct 25, 1999
PICCOLO SODIUM TEST SYSTEM
K993211
Abaxis, Inc.
Chemistry · 31d
Cleared May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346
Bayer Corp.
Chemistry · 106d
Cleared Mar 18, 1999
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036
Careside, Inc.
Chemistry · 71d
Cleared Nov 29, 1996
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K963763
Medica Corp.
Chemistry · 71d
Cleared Oct 24, 1996
EML105 ELECTROLYTE METABOLITE ANALYZER
K962334
Radiometer America, Inc.
Chemistry · 129d
Cleared Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542
Sigma Diagnostics, Inc.
Chemistry · 23d