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
73–96 of 162
Cleared Feb 11, 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 08, 1988
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263
Technicon Instruments Corp.
Chemistry · 48d
Cleared Nov 04, 1987
DART (R) ELECTROLYTE REAGENT SYSTEM
K874185
Coulter Electronics, Inc.
Chemistry · 21d
Cleared Oct 20, 1987
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074
American Monitor Corp.
Chemistry · 75d
Cleared Jul 31, 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716
Ciba Corning Diagnostics Corp.
Chemistry · 21d
Cleared Jun 24, 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K872190
Nova Biomedical Corp.
Chemistry · 16d
Cleared May 28, 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872
Medica Corp.
Chemistry · 91d
Cleared Oct 24, 1986
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617
Hi Chem, Inc.
Chemistry · 38d
Cleared Jul 01, 1986
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jun 13, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET
K861967
American Research Products Co.
Chemistry · 24d
Cleared Jul 12, 1985
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 12, 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Dec 11, 1984
CORNING 614 NA/K ANALYZER
K843530
Corning Medical & Scientific
Chemistry · 95d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 74d
Cleared Sep 27, 1984
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
K843452
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Jun 22, 1984
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025
Hi Chem, Inc.
Chemistry · 35d
Cleared Apr 04, 1984
REAGENTS & STANDARDS IL 501 NA/K
K840557
Shaban Mfg. Co.
Chemistry · 56d
Cleared Jan 24, 1984
TECHNICON RA-1000 SYSTEM
K833992
Technicon Instruments Corp.
Chemistry · 64d
Cleared Jan 13, 1984
NA/K FLUIDA PACK FOR NOVA 1 ANALYZER
K833712
Fisher Scientific Co., LLC
Chemistry · 84d
Cleared Nov 14, 1983
TECHNICON RA-1000 SYS-ISE MODULE &
K833072
Technicon Instruments Corp.
Chemistry · 67d
Cleared Nov 07, 1983
FLOW-PAC SODIUM REAGENT SET
K833036
American Research Products Co.
Chemistry · 61d
Cleared Nov 03, 1983
STARLYTE
K832744
Electro-Nucleonics Laboratories, Inc.
Chemistry · 80d
Cleared Aug 12, 1983
AMRESCO NA/K REAGENT SET
K832070
American Research Products Co.
Chemistry · 46d