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 Jun 30, 2008
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
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 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 May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346
Bayer Corp.
Chemistry · 106d
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
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
K955374
Medica Corp.
Chemistry · 91d
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM ANALYZER
K955375
Medica Corp.
Chemistry · 91d
Cleared Jun 20, 1995
SYNERMED ISE REAGENTS
K952179
Synermed, Inc.
Chemistry · 42d
Cleared Apr 26, 1994
EML 100
K935120
Radiometer America, Inc.
Chemistry · 181d
Cleared Apr 26, 1994
SYNERMED ISE REAGENTS
K941400
Synermed, Inc.
Chemistry · 35d
Cleared Apr 05, 1994
SYNERMED ISE REAGENTS
K940194
Synermed, Inc.
Chemistry · 82d
Cleared Aug 19, 1993
CIBA CORNING 300 SERIES SYSTEM
K933373
Ciba Corning Diagnostics Corp.
Chemistry · 38d
Cleared Apr 20, 1993
HI CHEM ELECTROLYTE BUFFER
K925612
Hichem Diagnostics
Chemistry · 166d
Cleared Feb 23, 1993
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611
Hichem Diagnostics
Chemistry · 110d
Cleared Jan 28, 1993
NOVA 8 CRT ANALYZER
K924547
Nova Biomedical Corp.
Chemistry · 141d