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
97–120 of 162
Cleared Aug 29, 1988
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
K882801
Hf Scientific, Inc.
Chemistry · 53d
Cleared Jul 05, 1988
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
K882104
Paramax Systems Div. Baxter Healthcare
Chemistry · 47d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750
Nova Biomedical Corp.
Chemistry · 128d
Cleared May 27, 1988
LYTENING 5
K880917
Amdev, Inc.
Chemistry · 85d
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 23, 1987
SODIUM/POTASSIUM REAGENT KIT
K873126
A-Kem, Inc.
Chemistry · 74d
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 May 12, 1987
IONOMETER EF AND ACCESSORIES
K870183
Smash Ent., Inc.
Chemistry · 116d
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872
Medica Corp.
Chemistry · 91d
Cleared Feb 20, 1987
REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
K864862
Hf Scientific, Inc.
Chemistry · 71d
Cleared Dec 10, 1986
MODIFIED SODIUM ELECTRODE
K863907
Ionetics, Inc.
Chemistry · 64d
Cleared Nov 05, 1986
LYTENING 2
K863521
Amdev, Inc.
Chemistry · 56d
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
Cleared Apr 07, 1986
AVL MODEL 983 ELECTROLYTE ANALYZER
K861087
Avl Scientific Corp.
Chemistry · 17d
Cleared Oct 04, 1985
LYTENING 1
K853832
Amdev, Inc.
Chemistry · 21d