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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

DateFirm and productCodeLinked 510(k)
Aug 5, 2025Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Open, Classified
JGSK200107
Dec 1, 2023Siemens Healthcare Diagnostics Inc
RAPIDPOINT 500 Blood Gas System
Open, Classified
JGSK113216
Dec 1, 2023Siemens Healthcare Diagnostics Inc
RAPIDPOINT 500e Blood Gas System
Open, Classified
JGSK192240
Nov 1, 2023Nova Biomedical Corporation
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63
Open, Classified
JGSK200403
Nov 1, 2023Nova Biomedical Corporation
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Pro
Open, Classified
JGSK200403
Nov 18, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Numb
Open, Classified
JGSK151767
May 18, 2021Siemens Healthcare Diagnostics, Inc.
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in rand
Terminated
JGSK990346
May 13, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Open, Classified
JGSK151767
May 4, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Open, Classified
JGSK151767
Dec 2, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of
Terminated
JGSK151767
Mar 2, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Open, Classified
JGSK161954
Feb 27, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Terminated
JGSK151767
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, bl
Terminated
JGSNone listed
Dec 9, 2019Mindray DS USA, Inc. dba Mindray North America
ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear s
Terminated
JGSK160370
Dec 9, 2019Mindray DS USA, Inc. dba Mindray North America
BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (0
Terminated
JGSK160370
Oct 11, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro
Terminated
JGSK151767
Jul 30, 2019Siemens Healthcare Diagnostics, Inc.
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Terminated
JGSK151767
Mar 7, 2019Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime, Material Number 11069001
Terminated
JGSK161954
Jan 22, 2019Ortho-Clinical Diagnostics
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VI
Terminated
JGSK081411
May 5, 2018Ortho-Clinical Diagnostics
VITROS Sodium Slides, Catalog # 837 9034
Terminated
JGSK924471
Feb 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Terminated
JGSK161954
Dec 20, 2016Ortho-Clinical Diagnostics
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1
Terminated
JGSK081411
Aug 28, 2015Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random
Terminated
JGSK990346
Apr 7, 2015Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyz
Terminated
JGSK990346
Feb 25, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum,
Terminated
JGSK081411
K924471
Jan 23, 2014Radiometer America Inc
ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole b
Terminated
JGSK092686
Nov 18, 2013Siemens Healthcare Diagnostics
ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Terminated
JGSNone listed
Nov 18, 2013Siemens Healthcare Diagnostics
ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Terminated
JGSNone listed
Nov 18, 2013Siemens Healthcare Diagnostics
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring
Terminated
JGSK990346
Nov 18, 2013Siemens Healthcare Diagnostics
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring
Terminated
JGSK990346
Apr 18, 2013Horiba Instruments, Inc dba Horiba Medical
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Terminated
JGSK052007
Jan 10, 2012Vital Scientific N.V.
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Terminated
JGSK102647
Jan 10, 2012Vital Scientific N.V.
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Terminated
JGSK102647
Apr 26, 2011Beckman Coulter Inc.
Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer and the Access 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry
Terminated
JGSK023049
Apr 18, 2011Abbott Point Of Care Inc.
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyt
Terminated
JGSK053110
Sep 21, 2008Beckman Coulter Inc
SYNCHRON LXi 725 System
Terminated
JGSK023049
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
Terminated
JGSK001154
K894914 +1
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
Terminated
JGSK001154
K894914 +2
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
Terminated
JGSK973292
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
Terminated
JGSK001154
K894914 +1
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
Terminated
JGSK894914
K912387
Dec 11, 2007Abbott Point of Care Inc.
Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
Terminated
JGSK001154
K912387
Nov 9, 2007Opti Medical Systems Inc
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Terminated
JGSK052027
Aug 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Terminated
JGSK990346
Aug 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Terminated
JGSK990346
Aug 29, 2006Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Terminated
JGSK990346
Jun 22, 2006Abbott Laboratories
i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catal
Terminated
JGSK894914
Feb 5, 2003Beckman Coulter Inc
SYNCHRON LX20 AND LX20 Pro
Terminated
JGSK011213
K014034 +1

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