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
49–72 of 162
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
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 49d
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 Nov 17, 1993
MODEL 400/450 ELECTROLYTE ANALYZER
K932179
Ionetics, Inc.
Chemistry · 196d
Cleared Oct 12, 1993
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862
Schiapparelli Biosystems, Inc.
Chemistry · 64d
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
Cleared Nov 06, 1992
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471
Eastman Kodak Company
Chemistry · 65d
Cleared Sep 29, 1992
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
K923806
Nova Biomedical Corp.
Chemistry · 62d
Cleared Jul 27, 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937
Nova Biomedical Corp.
Chemistry · 94d
Cleared Jul 21, 1992
OLYMPUS ISE MODULE
K921718
Olympus Corp.
Chemistry · 103d