Product Code: JGS
FDA class 2
21 CFR 862.1665
Electrode, Ion Specific, Sodium
Clinical Chemistry
An Ion-Specific Electrode for Sodium is a clinical chemistry device that uses selective ion electrodes to measure sodium ion concentration in blood or other biological specimens, essential for monitoring electrolyte balance, hydration status, and conditions such as hyponatremia and hypernatremia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JGS, regulated under 21 CFR 862.1665, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
161
FEI Numbers
90
Registration Numbers
90
Unique Applicants
86
Years Active
46
Basic Information
- Product Code
- JGS
- Device Class
- FDA class 2
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 161 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | Oct 27, 2023 | Substantially Equivalent | Abbott Point of Care Inc. |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Jul 25, 2023 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Jul 20, 2023 | Substantially Equivalent | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
| K213486 | GLP systems Track | Mar 10, 2022 | Substantially Equivalent | Abbott Laboratories |
| K200403 | Stat Profile Prime Plus Analyzer System | Apr 14, 2020 | Substantially Equivalent | Nova Biomedical Corporation |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Feb 07, 2020 | Substantially Equivalent | Abbott Point of Care, Inc. |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Jul 19, 2019 | Substantially Equivalent | Nova Biomedical Corporation |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 | Jun 12, 2019 | Substantially Equivalent | AMS Diagnostics |
| K183549 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent | Instrumentation Laboratory Co. |
| K180428 | Stat Profile Prime Plus Analyzer System | Aug 15, 2018 | Substantially Equivalent | Nova Biomedical Corporation |
| K181201 | Synermed ISE Reagents | Jul 10, 2018 | Substantially Equivalent | Infrared Laboratory Systems, LLC (dba Synermed) |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Feb 27, 2018 | Substantially Equivalent | Awareness Technology, Inc. |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | Mar 09, 2017 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | Dec 16, 2016 | Substantially Equivalent | BECKMAN COULTER INC. |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator | Dec 14, 2016 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K153357 | i-STAT Alinity System with i-STAT Sodium test | Jul 08, 2016 | Substantially Equivalent | ABBOTT POINT OF CARE INC. |
| K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer | Jun 09, 2016 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator | Dec 11, 2015 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K140373 | ISE INDIRECT NA, K, C1 FOR GEN 2 | May 22, 2014 | Substantially Equivalent | Roche Diagnostics |
| K132418 | COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 | Dec 18, 2013 | Substantially Equivalent | Roche Diagnostics |
| K123726 | COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 | May 21, 2013 | Substantially Equivalent | Roche Diagnostics |
| K121140 | PROLYTE ELECTROLYTE ANALYZER | Aug 22, 2012 | Substantially Equivalent | DIAMOND DIAGNOSTICS, INC |
| K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... | Mar 24, 2011 | Substantially Equivalent | ELITECHGROUP VITAL SCIENTIFIC BV |
| K102959 | PROLYTE ELECTROLYTE ANALYZER | Jan 14, 2011 | Substantially Equivalent | DIAMOND DIAGNOSTICS, INC. |
| K100829 | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 | Jan 14, 2011 | Substantially Equivalent | MEDICA CORP. |
| K100673 | EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 | Apr 06, 2010 | Substantially Equivalent | MEDICA CORP. |
| K091861 | VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 | Sep 03, 2009 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K082462 | GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ | Feb 06, 2009 | Substantially Equivalent | DIAMOND DIAGNOSTICS, INC. |
| K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | Jun 30, 2008 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K070104 | PROLYTE ELECTROLYTE ANALYZER | May 07, 2008 | Substantially Equivalent | DIAMOND DIAGNOSTICS, INC. |
| K061597 | EPOC BLOOD ANALYSIS SYSTEM | Sep 27, 2006 | Substantially Equivalent | EPOCAL, INC. |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge | Jan 13, 2006 | Substantially Equivalent | I-STAT CORPORATION |
| K053165 | ISE INDIRECT NA, K, CL FOR GEN.2 | Dec 14, 2005 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K052724 | TECO ISE REAGENT SET FOR CX SYSTEM | Dec 14, 2005 | Substantially Equivalent | TECO DIAGNOSTICS |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | Oct 07, 2005 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K040977 | GENCHEM ELECTROLYTE BUFFER | Dec 27, 2004 | Substantially Equivalent | GENCHEM, INC. |
| K040971 | GENCHEM ISE ELECTROLYTE REFERENCE | Dec 22, 2004 | Substantially Equivalent | GENCHEM, INC. |
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM | Oct 04, 2002 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS | Jun 04, 2002 | Substantially Equivalent | PHOENIX DIAGNOSTICS, INC. |
| K011213 | MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM | May 16, 2001 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K002407 | EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER | Feb 02, 2001 | Substantially Equivalent | MEDICA CORP. |
| K002855 | BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER | Oct 12, 2000 | Substantially Equivalent | BIOCARE CORP. |
| K001761 | STATLYTE NA/K/CL/LI ANALYZER | Aug 07, 2000 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER | Apr 18, 2000 | Substantially Equivalent | I-STAT CORP. |
| K000895 | STAT PROFILE PHOX PLUS ANALYZER | Apr 17, 2000 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K992844 | HICHEM ISE ELECTROLYTE BUFFER | Nov 26, 1999 | Substantially Equivalent | ELAN HOLDINGS, INC. |
| K992842 | HICHEM ISE ELECTROLYTE REFERENCE | Nov 26, 1999 | Substantially Equivalent | ELAN HOLDINGS, INC. |
| K993211 | PICCOLO SODIUM TEST SYSTEM | Oct 25, 1999 | Substantially Equivalent | ABAXIS, INC. |
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM | May 21, 1999 | Substantially Equivalent | BAYER CORP. |
| K990036 | CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 | Mar 18, 1999 | Substantially Equivalent | CARESIDE, INC. |
| K963763 | EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER | Nov 29, 1996 | Substantially Equivalent | MEDICA CORP. |
| K963627 | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE | Oct 24, 1996 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | Oct 24, 1996 | Substantially Equivalent | RADIOMETER AMERICA, INC. |
| K963542 | SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT | Sep 27, 1996 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K961099 | EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) | May 07, 1996 | Substantially Equivalent | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
| K955375 | EASYSTAT SODIUM/POTASSIUM ANALYZER | Feb 23, 1996 | Substantially Equivalent | MEDICA CORP. |
| K955374 | EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER | Feb 23, 1996 | Substantially Equivalent | MEDICA CORP. |
| K952179 | SYNERMED ISE REAGENTS | Jun 20, 1995 | Substantially Equivalent | SYNERMED, INC. |
| K941400 | SYNERMED ISE REAGENTS | Apr 26, 1994 | Substantially Equivalent | SYNERMED, INC. |
| K935120 | EML 100 | Apr 26, 1994 | Substantially Equivalent | RADIOMETER AMERICA, INC. |
| K940194 | SYNERMED ISE REAGENTS | Apr 05, 1994 | Substantially Equivalent | SYNERMED, INC. |
| K932179 | MODEL 400/450 ELECTROLYTE ANALYZER | Nov 17, 1993 | Substantially Equivalent | IONETICS, INC. |
| K933862 | ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) | Oct 12, 1993 | Substantially Equivalent | SCHIAPPARELLI BIOSYSTEMS, INC. |
| K933373 | CIBA CORNING 300 SERIES SYSTEM | Aug 19, 1993 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K925612 | HI CHEM ELECTROLYTE BUFFER | Apr 20, 1993 | Substantially Equivalent | HICHEM DIAGNOSTICS |
| K925611 | HI CHEM ELECTROLYTE REFERENCE REAGENT | Feb 23, 1993 | Substantially Equivalent | HICHEM DIAGNOSTICS |
| K924547 | NOVA 8 CRT ANALYZER | Jan 28, 1993 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K924471 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) | Nov 06, 1992 | Substantially Equivalent | EASTMAN KODAK COMPANY |
| K923806 | ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER | Sep 29, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K921937 | NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION | Jul 27, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K921718 | OLYMPUS ISE MODULE | Jul 21, 1992 | Substantially Equivalent | OLYMPUS CORP. |
| K922215 | NOVA 14 NA/K/CL/GLU/BUN ANALYZER | Jul 17, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K915176 | NOVA 4 NA/K/C1/TCO2/LI ANALYZER | Jan 15, 1992 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K914810 | EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER | Dec 04, 1991 | Substantially Equivalent | MEDICA CORP. |
| K903564 | MEDISENSOR 2001 | Sep 30, 1991 | Substantially Equivalent | MEDTEST SYSTEMS, INC. |
| K912648 | ISE/NA+ | Jul 17, 1991 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K912560 | NOVA 12 ANALYZER | Jul 17, 1991 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K912559 | NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER | Jul 01, 1991 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K912387 | I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK | Jul 01, 1991 | Substantially Equivalent | I-STAT CORP. |
| K912016 | IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER | Jun 10, 1991 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K910305 | GEM-PREMIER SYSTEM | Apr 03, 1991 | Substantially Equivalent | MALLINCKRODT SENSOR SYSTEMS, INC. |
| K910554 | CLINAK(TM) ISE SUBSYSTEM | Mar 06, 1991 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K905264 | STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS | Mar 05, 1991 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K905600 | TECHLYTE ELECTROLYTE ANALYZER | Jan 15, 1991 | Substantially Equivalent | TECHNALYSIS, INC. |
| K904335 | SECONDARY CALIBRATORS | Oct 12, 1990 | Substantially Equivalent | BIONOSTICS, INC. |
| K903188 | ABBOTT VISION LYTE (TM) SODIUM | Sep 10, 1990 | Substantially Equivalent | ABBOTT LABORATORIES |
| K901042 | IONOMETER EF-HK AND ACCESSORIES | Jul 31, 1990 | Substantially Equivalent | FRESENIUS USA, INC. |
| K901040 | IONOMETER EH-F AND ACCESSORIES | Jul 19, 1990 | Substantially Equivalent | FRESENIUS USA, INC. |
| K896526 | LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 | Jan 02, 1990 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K895936 | EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER | Dec 12, 1989 | Substantially Equivalent | MEDICA CORP. |
| K894035 | EOS CHEMISTRY ANALYZER | Oct 31, 1989 | Substantially Equivalent | EOS TECHNOLOGY CORP. |
| K895672 | TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD | Oct 25, 1989 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K894914 | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK | Oct 16, 1989 | Substantially Equivalent | I-STAT CORP. |
| K894218 | NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM | Sep 07, 1989 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K892500 | CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE | Jul 20, 1989 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K882801 | RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. | Aug 29, 1988 | Substantially Equivalent | HF SCIENTIFIC, INC. |
| K882104 | ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. | Jul 05, 1988 | Substantially Equivalent | PARAMAX SYSTEMS DIV. BAXTER HEALTHCARE |
| K880750 | NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT | Jul 01, 1988 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K880917 | LYTENING 5 | May 27, 1988 | Substantially Equivalent | AMDEV, INC. |
| K881255 | NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA | May 16, 1988 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K874832 | NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL | Feb 11, 1988 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K875263 | ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) | Feb 08, 1988 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K874185 | DART (R) ELECTROLYTE REAGENT SYSTEM | Nov 04, 1987 | Substantially Equivalent | COULTER ELECTRONICS, INC. |
| K873126 | SODIUM/POTASSIUM REAGENT KIT | Oct 23, 1987 | Substantially Equivalent | A-KEM, INC. |
| K873074 | SODIUM AND POTASSIUM BY ION SELECTIVE | Oct 20, 1987 | Substantially Equivalent | AMERICAN MONITOR CORP. |
| K872716 | CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE | Jul 31, 1987 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K872190 | NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER | Jun 24, 1987 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K871028 | CIBA CORNING MODEL 664/FAST 4 SYSTEM | May 28, 1987 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K870183 | IONOMETER EF AND ACCESSORIES | May 12, 1987 | Substantially Equivalent | SMASH ENT., INC. |
| K864872 | MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER | Mar 13, 1987 | Substantially Equivalent | MEDICA CORP. |
| K864862 | REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. | Feb 20, 1987 | Substantially Equivalent | HF SCIENTIFIC, INC. |
| K863907 | MODIFIED SODIUM ELECTRODE | Dec 10, 1986 | Substantially Equivalent | IONETICS, INC. |
| K863521 | LYTENING 2 | Nov 05, 1986 | Substantially Equivalent | AMDEV, INC. |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | Oct 24, 1986 | Substantially Equivalent | HI CHEM, INC. |
| K862819 | AVL MODEL 984 ELECTROLYTE ANALYZER | Aug 29, 1986 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K861696 | ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 | Jul 01, 1986 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K861967 | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET | Jun 13, 1986 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K861087 | AVL MODEL 983 ELECTROLYTE ANALYZER | Apr 07, 1986 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K853832 | LYTENING 1 | Oct 04, 1985 | Substantially Equivalent | AMDEV, INC. |
| K852595 | DC-3 FLUIDS PACK, DC-5 FLUIDS PACK | Jul 12, 1985 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K852473 | ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA | Jul 12, 1985 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K850209 | QUICK-LYTE | Feb 27, 1985 | Substantially Equivalent | SERAGEN DIAGNOSTICS, INC. |
| K844587 | AVL MODEL 982 ELECTROLYTE ANALYZER | Jan 18, 1985 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
| K844559 | MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI | Jan 18, 1985 | Substantially Equivalent | THERMO ORION |
| K843530 | CORNING 614 NA/K ANALYZER | Dec 11, 1984 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K843453 | ULTRA LYTE SODIUM REAGENT KIT | Nov 27, 1984 | Substantially Equivalent | ULTRA QUEST DIAGNOSTICS, INC. |
| K842873 | STANDARDS & ACCESSORIES FOR NOVA INSTRU | Oct 05, 1984 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K843452 | STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ | Sep 27, 1984 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K842025 | ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL | Jun 22, 1984 | Substantially Equivalent | HI CHEM, INC. |
| K841424 | ELECTROLYTE ANALYZER SERA-210 | Jun 22, 1984 | Substantially Equivalent | HORIBA INSTRUMENTS, INC. |
| K841418 | SODIUM ELECTRODE RINSE SOLUTION 2 | May 16, 1984 | Substantially Equivalent | REAGENT LABORATORY, INC. |
| K841417 | POTASSIUM CHLORIDE SOLUTION -2 MOLAR | May 16, 1984 | Substantially Equivalent | REAGENT LABORATORY, INC. |
| K840557 | REAGENTS & STANDARDS IL 501 NA/K | Apr 04, 1984 | Substantially Equivalent | SHABAN MFG. CO. |
| K833992 | TECHNICON RA-1000 SYSTEM | Jan 24, 1984 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K833712 | NA/K FLUIDA PACK FOR NOVA 1 ANALYZER | Jan 13, 1984 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K833072 | TECHNICON RA-1000 SYS-ISE MODULE & | Nov 14, 1983 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K833036 | FLOW-PAC SODIUM REAGENT SET | Nov 07, 1983 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K832744 | STARLYTE | Nov 03, 1983 | Substantially Equivalent | ELECTRO-NUCLEONICS LABORATORIES, INC. |
| K832415 | DEPROTEINIZING & CLEANING SOLUTION | Sep 12, 1983 | Substantially Equivalent | SHABAN MFG. CO. |
| K832070 | AMRESCO NA/K REAGENT SET | Aug 12, 1983 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K830589 | ELECTROLYTE STANDARD - CORNING NALK ISE | Apr 27, 1983 | Substantially Equivalent | SHABAN MFG. CO. |
| K830588 | POTASSIUM ANALYZER-SODIUM/ELECTROLYTE | Apr 27, 1983 | Substantially Equivalent | SHABAN MFG. CO. |
| K822039 | BECKMAN ASTRA | Oct 21, 1982 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K820395 | LIQUIZYME NA+/K+ REAGENT SET | Mar 11, 1982 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K812762 | IL 501, NA/K ANALYZER | Oct 20, 1981 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K811896 | 902 NA/K | Jul 23, 1981 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K811289 | NOVA 5 | May 27, 1981 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K810135 | MODEL AM 721 ELECTROLYTE ANALYZER | Feb 10, 1981 | Substantially Equivalent | ABBOTT DIAGNOSTICS |
| K802155 | REAGENTS SERUM SODIUM USING THE TECH. | Oct 10, 1980 | Substantially Equivalent | PANMED, INC. |
| K801896 | BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM | Sep 16, 1980 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K801882 | NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON | Sep 16, 1980 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | Sep 16, 1980 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K801011 | AVL #980 ELECTROLYTE ANALYZER | Jul 08, 1980 | Substantially Equivalent | GAUNTLET TECHNOLOGY CORP. |
| K800676 | REAGENTS FOR DETERM. SODIUM IN HUMAN SUM | May 28, 1980 | Substantially Equivalent | DIAGNOSTIC SOLUTIONS, INC. |
| K801007 | IL SYSTEM 502 NA/K ANALYZER | May 14, 1980 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K800628 | KODAK EKTACHEM CLINICAL CHEM. SLIDES | Apr 10, 1980 | Substantially Equivalent | EASTMAN KODAK COMPANY |
| K800584 | NSI SODIUM/POTASSIUM KIT | Apr 02, 1980 | Substantially Equivalent | NOBEL SCIENTIFIC INDUSTRIES, INC. |
| K800216 | SODIUM/POTASSIUM CONDITIONING REAGENT | Feb 26, 1980 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K791691 | SODIUM/POTASSIUM CONDITIONING SOLUTION | Sep 17, 1979 | Substantially Equivalent | HI CHEM, INC. |
| K771839 | SODIUM | Nov 02, 1977 | Substantially Equivalent | GAMMA ENTERPRISES, INC. |
| K770601 | ANALYZER, SODIUM/POTASSIUM NOVA L | Jun 14, 1977 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
FEI Numbers
This FDA classification entry is associated with 90 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 90 registration numbers. Click on an entry to view related FDA registrations.