Panels › Clinical Chemistry › Product code CEM · Class 2
Electrode, Ion Specific, Potassium
Regulation 862.1600
1510(k)s in 12 months (89 all time)
3recalls in 12 months (63 all time)
61recalls that name a 510(k)
Top companies in CEM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 800
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistrie Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 800 PRO
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemis Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 880i
The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Sampl Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 660i
The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Sampl Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 680i
The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Sampl Terminated |
CEM | K042291 |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC860i
The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Sample Terminated |
CEM | K042291 |
| Mar 9, 2011 | Beckman Coulter Inc. GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640;
SYNCHRON and UniCel Systems and Part Numbers:
Synchron LX20, Part Number: 466200,
Terminated |
CEM | K011213 K023049 +4 |
| Feb 2, 2011 | Radiometer America Inc ABL90 FLEX Blood Analyzer Part Number: 393-090.
Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care se Terminated |
CEM | K092686 |
| Oct 25, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Standard A, Catalog No K820
For the calibration of Na+/K+/Cl- on the Dimension vista System. Terminated |
CEM | K051087 |
| Feb 6, 2009 | Epocal EPOC BGE Test Card
The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the labo Terminated |
CEM | K061597 |
| Aug 29, 2006 | Roche Diagnostics Corp. Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 108254 Terminated |
CEM | K953239 |
| Aug 3, 2006 | Roche Diagnostics Corp. Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825 Terminated |
CEM | K953239 |
| Jun 28, 2005 | Beckman Coulter Inc Potassium Electrode Tip;
Part No.s:
668281 Tip Assembly- Synchron Family
669117 Packaged- Synchron Family
441104 Electrode Assembly- EL-ISE
445604 Electrode Packaged- EL-ISE Terminated |
CEM | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.