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)
Top companies in JGS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Open, Classified |
JGS | K200107 |
| Dec 1, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPOINT 500 Blood Gas System Open, Classified |
JGS | K113216 |
| Dec 1, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPOINT 500e Blood Gas System Open, Classified |
JGS | K192240 |
| Nov 1, 2023 | Nova 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 |
JGS | K200403 |
| Nov 1, 2023 | Nova 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 |
JGS | K200403 |
| Nov 18, 2021 | Siemens 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 |
JGS | K151767 |
| May 18, 2021 | Siemens 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 |
JGS | K990346 |
| May 13, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11067000 Open, Classified |
JGS | K151767 |
| May 4, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676)
Siemens Material Number: 11067000 Open, Classified |
JGS | K151767 |
| Dec 2, 2020 | Siemens 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 |
JGS | K151767 |
| Mar 2, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Open, Classified |
JGS | K161954 |
| Feb 27, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower Terminated |
JGS | K151767 |
| Feb 18, 2020 | Abbott 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 |
JGS | None listed |
| Dec 9, 2019 | Mindray 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 |
JGS | K160370 |
| Dec 9, 2019 | Mindray 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 |
JGS | K160370 |
| Oct 11, 2019 | Siemens 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 |
JGS | K151767 |
| Jul 30, 2019 | Siemens 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 |
JGS | K151767 |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica Sample Handler Prime, Material Number 11069001 Terminated |
JGS | K161954 |
| Jan 22, 2019 | Ortho-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 |
JGS | K081411 |
| May 5, 2018 | Ortho-Clinical Diagnostics VITROS Sodium Slides, Catalog # 837 9034 Terminated |
JGS | K924471 |
| Feb 26, 2018 | Siemens Healthcare Diagnostics, Inc. Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens. Terminated |
JGS | K161954 |
| Dec 20, 2016 | Ortho-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 |
JGS | K081411 |
| Aug 28, 2015 | Siemens 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 |
JGS | K990346 |
| Apr 7, 2015 | Siemens 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 |
JGS | K990346 |
| Feb 25, 2014 | Ortho-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 |
JGS | K081411 K924471 |
| Jan 23, 2014 | Radiometer 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 |
JGS | K092686 |
| Nov 18, 2013 | Siemens 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 |
JGS | None listed |
| Nov 18, 2013 | Siemens 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 |
JGS | None listed |
| Nov 18, 2013 | Siemens 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 |
JGS | K990346 |
| Nov 18, 2013 | Siemens 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 |
JGS | K990346 |
| Apr 18, 2013 | Horiba 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 |
JGS | K052007 |
| Jan 10, 2012 | Vital Scientific N.V. Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418
Product Usage: :clinical chemistry system intended for use in clinical laboratories. Terminated |
JGS | K102647 |
| Jan 10, 2012 | Vital 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 |
JGS | K102647 |
| Apr 26, 2011 | Beckman 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 |
JGS | K023049 |
| Apr 18, 2011 | Abbott 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 |
JGS | K053110 |
| Sep 21, 2008 | Beckman Coulter Inc SYNCHRON LXi 725 System Terminated |
JGS | K023049 |
| Dec 11, 2007 | Abbott 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 |
JGS | K001154 K894914 +1 |
| Dec 11, 2007 | Abbott 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 |
JGS | K001154 K894914 +2 |
| Dec 11, 2007 | Abbott 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 |
JGS | K973292 |
| Dec 11, 2007 | Abbott 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 |
JGS | K001154 K894914 +1 |
| Dec 11, 2007 | Abbott 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 |
JGS | K894914 K912387 |
| Dec 11, 2007 | Abbott 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 |
JGS | K001154 K912387 |
| Nov 9, 2007 | Opti Medical Systems Inc OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076 Terminated |
JGS | K052027 |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | K990346 |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | K990346 |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | K990346 |
| Jun 22, 2006 | Abbott 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 |
JGS | K894914 |
| Feb 5, 2003 | Beckman Coulter Inc SYNCHRON LX20 AND LX20 Pro Terminated |
JGS | K011213 K014034 +1 |
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