510(k) K042291 ยท CEM Electrode, Ion Specific, Potassium
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 12, 2004 |
| Received | Aug 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2020 | Beckman Coulter Inc. ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma. Terminated |
JFL | None listed |
| Mar 30, 2019 | Beckman Coulter Inc. UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an au Open, Classified |
JJE | None listed |
| Jul 22, 2016 | Beckman Coulter Inc. UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from th Terminated |
JJE | None listed |
| Sep 23, 2014 | Beckman Coulter Inc. UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human b Terminated |
JJE | None listed |
| Jun 9, 2014 | Beckman Coulter Inc. Ultrasonic Transducer Kits
For use with the Access Family of Immunoassay Systems*.
*The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600,
UniCel DxC 600i, Terminated |
JJE | None listed |
| Nov 19, 2012 | Beckman Coulter Inc. UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102.
The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, s Terminated |
CEM | None listed |
| Oct 24, 2012 | Beckman Coulter Inc. UniCel DxC 600/800 with
Software v5.0.11, Part Number B12218.
The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro d Terminated |
JJE | None listed |
| Oct 12, 2012 | Beckman Coulter Inc. Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853.
Product Usage: The UniCel DxC Synch Terminated |
JJE | None listed |
| Aug 23, 2012 | Beckman Coulter Inc. UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100;
Dxl 800 Remanufactured: A25288;
Dxl 800 with spot B: A71456;
Dxl 800 Reconditioned: A25285.
The DxI Immunoassay System is an Terminated |
JJE | None listed |
| Aug 23, 2012 | Beckman Coulter Inc. UniCel DxI 600 Access Immunoassay Systems, Part Numbers:
Dxl 600: A30260;
Dxl 600 with spot B: A71460.
The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-qu Terminated |
JJE | None listed |
| Aug 23, 2012 | Beckman Coulter Inc. UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems,
Part Numbers:
DxC 660i: A64871;
DxC 680i: A64903;
DxC 860i: A64935;
DxC 880i: A59102.
The DxI Immunoassay System is an in vitro Terminated |
JJE | None listed |
| Jun 28, 2011 | Beckman Coulter Inc. Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software version 4.3 Terminated |
JJE | None listed |
| Jun 23, 2011 | Beckman Coulter Inc. Tubing Assembly #142, V2, V12 Mixer/Wash a component of
the DxC instruments.
Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinica Terminated |
JJE | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 600i
The UniCel DxC SynchronClinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistri Terminated |
CEM | None listed |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel 600 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 chemistrie Terminated |
CEM | None listed |
| Apr 26, 2011 | Beckman Coulter Inc. UniCel DxC 600
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 | None listed |
| Apr 13, 2011 | Beckman Coulter Inc. UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405,
UniCel DxC 600 PRO Part #: A11810,
UniCel DxC 600i Part #: A27318,
UniCel DxC 660i Part #: A648 Terminated |
JJE | None listed |
| Apr 11, 2011 | Beckman Coulter Inc. UniCel DxI 800 Access Immunoassay
Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured
A25288, DxI 800 with spot B A71456, DxI 800
Reconditioned A25285
The DxI Immunoassay System is an in Terminated |
JJE | None listed |
| Apr 11, 2011 | Beckman Coulter Inc. UniCel DxI 600 Access Immunoassay
Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460
The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quant Terminated |
JJE | None listed |
| Apr 11, 2011 | Beckman Coulter Inc. UniCel DxC 660i, 680i, 860i, 880i
SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903,
DxC860i: A64935, DxC 880i: A59102
The DxI Immunoassay System is an in vitro diag Terminated |
JJE | None listed |
| 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 | None listed |
| Sep 9, 2010 | Beckman Coulter Inc. GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel D Terminated |
CGA | None listed |
| Mar 4, 2010 | Beckman Coulter Inc. Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell.
PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel D Terminated |
JJE | None listed |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc. Terminated |
JJE | None listed |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc. Terminated |
JJE | None listed |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc. Terminated |
JJE | None listed |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc. Terminated |
JJE | None listed |
| May 25, 2006 | Beckman Coulter Inc Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.