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 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 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
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 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
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 Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
K910554
Baxter Healthcare Corp
Chemistry · 34d