ClearanceBrief
Panels › Clinical Chemistry › Product code JGS · Class 2

Electrode, Ion Specific, Sodium

Regulation 862.1665

1510(k)s in 12 months (162 all time)
0recalls in 12 months (48 all time)
45recalls that name a 510(k)
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Top companies in JGS

Company510(k)sRecalls
Nova Biomedical Corp.212
Siemens Healthcare Diagnostics320
Abbott Point of Care, Inc.38
Medica Corp.90
Beckman Coulter, Inc.33
Ortho-Clinical Diagnostics, Inc.24
Instrumentation Laboratory CO50
American Research Products Co.40
Ciba Corning Diagnostics Corp.40
Diamond Diagnostics, Inc.40
Decided510(k)Device and applicantCode
Mar 18, 1999K990036CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
Careside, Inc.
JGS
Nov 29, 1996K963763EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
Medica Corp.
JGS
Oct 24, 1996K963627(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
Roche Diagnostic Systems, Inc.
JGS
Oct 24, 1996K962334EML105 ELECTROLYTE METABOLITE ANALYZER
Radiometer America, Inc.
JGS
Sep 27, 1996K963542SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
Sigma Diagnostics, Inc.
JGS
May 7, 1996K961099EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
Johnson & Johnson Clinical Diagnostics, Inc.
JGS
Feb 23, 1996K955375EASYSTAT SODIUM/POTASSIUM ANALYZER
Medica Corp.
JGS
Feb 23, 1996K955374EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
Medica Corp.
JGS
Jun 20, 1995K952179SYNERMED ISE REAGENTS
Synermed, Inc., CA
JGS
Apr 26, 1994K941400SYNERMED ISE REAGENTS
Synermed, Inc., CA
JGS
Apr 26, 1994K935120EML 100
Radiometer America, Inc.
JGS
Apr 5, 1994K940194SYNERMED ISE REAGENTS
Synermed, Inc., CA
JGS
Nov 17, 1993K932179MODEL 400/450 ELECTROLYTE ANALYZER
Ionetics, Inc.
JGS
Oct 12, 1993K933862ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
Schiapparelli Biosystems, Inc.
JGS
Aug 19, 1993K933373CIBA CORNING 300 SERIES SYSTEM
Ciba Corning Diagnostics Corp.
JGS
Apr 20, 1993K925612HI CHEM ELECTROLYTE BUFFER
Hichem Diagnostics
JGS
Feb 23, 1993K925611HI CHEM ELECTROLYTE REFERENCE REAGENT
Hichem Diagnostics
JGS
Jan 28, 1993K924547NOVA 8 CRT ANALYZER
Nova Biomedical Corp.
JGS
Nov 6, 1992K924471KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
Eastman Kodak Company
JGS
Sep 29, 1992K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
Nova Biomedical Corp.
JGS
Jul 27, 1992K921937NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
Nova Biomedical Corp.
JGS
Jul 21, 1992K921718OLYMPUS ISE MODULE
Olympus Corp.
JGS
Jul 17, 1992K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZER
Nova Biomedical Corp.
JGS
Jan 15, 1992K915176NOVA 4 NA/K/C1/TCO2/LI ANALYZER
Nova Biomedical Corp.
JGS
Dec 4, 1991K914810EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER
Medica Corp.
JGS
Sep 30, 1991K903564MEDISENSOR 2001
Medtest Systems, Inc.
JGS
Jul 17, 1991K912648ISE/NA+
Boehringer Mannheim Corp.
JGS
Jul 17, 1991K912560NOVA 12 ANALYZER
Nova Biomedical Corp.
JGS
Jul 1, 1991K912559NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
Nova Biomedical Corp.
JGS
Jul 1, 1991K912387I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
I-Stat Corp.
JGS
Jun 10, 1991K912016IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
Instrumentation Laboratory CO
JGS
Apr 3, 1991K910305GEM-PREMIER SYSTEM
Mallinckrodt Sensor Systems, Inc.
JGS
Mar 6, 1991K910554CLINAK(TM) ISE SUBSYSTEM
Baxter Healthcare Corp
JGS
Mar 5, 1991K905264STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
Nova Biomedical Corp.
JGS
Jan 15, 1991K905600TECHLYTE ELECTROLYTE ANALYZER
Technalysis, Inc.
JGS
Oct 12, 1990K904335SECONDARY CALIBRATORS
Bionostics, Inc.
JGS
Sep 10, 1990K903188ABBOTT VISION LYTE (TM) SODIUM
Abbott Laboratories
JGS
Jul 31, 1990K901042IONOMETER EF-HK AND ACCESSORIES
Fresenius USA, Inc.
JGS
Jul 19, 1990K901040IONOMETER EH-F AND ACCESSORIES
Fresenius USA, Inc.
JGS
Jan 2, 1990K896526LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
Baxter Healthcare Corp
JGS
Dec 12, 1989K895936EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
Medica Corp.
JGS
Oct 31, 1989K894035EOS CHEMISTRY ANALYZER
Eos Technology Corp.
JGS
Oct 25, 1989K895672TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
Technicon Instruments Corp.
JGS
Oct 16, 1989K894914MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
I-Stat Corp.
JGS
Sep 7, 1989K894218NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
Nova Biomedical Corp.
JGS
Jul 20, 1989K892500CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
Ciba Corning Diagnostics Corp.
JGS
Aug 29, 1988K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
Hf Scientific, Inc.
JGS
Jul 5, 1988K882104ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
Paramax Systems Div. Baxter Healthcare
JGS
Jul 1, 1988K880750NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
Nova Biomedical Corp.
JGS
May 27, 1988K880917LYTENING 5
Amdev, Inc.
JGS

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