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 Mar 05, 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
K905264
Nova Biomedical Corp.
Chemistry · 104d
Cleared Oct 12, 1990
SECONDARY CALIBRATORS
K904335
Bionostics, Inc.
Chemistry · 22d
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188
Abbott Laboratories
Chemistry · 53d
Cleared Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042
Fresenius USA, Inc.
Chemistry · 147d
Cleared Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040
Fresenius USA, Inc.
Chemistry · 135d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526
Baxter Healthcare Corp
Chemistry · 50d
Cleared Dec 12, 1989
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936
Medica Corp.
Chemistry · 62d
Cleared Oct 25, 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672
Technicon Instruments Corp.
Chemistry · 35d
Cleared Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218
Nova Biomedical Corp.
Chemistry · 80d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750
Nova Biomedical Corp.
Chemistry · 128d
Cleared May 16, 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255
Nova Biomedical Corp.
Chemistry · 54d
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 Aug 29, 1986
AVL MODEL 984 ELECTROLYTE ANALYZER
K862819
Avl Scientific Corp.
Chemistry · 36d
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