ClearanceBrief
510(k) K042291 ยท CEM Electrode, Ion Specific, Potassium

UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

ApplicantBeckman Coulter, Inc., Brea CA, US
DecisionSubstantially Equivalent, Nov 12, 2004
ReceivedAug 24, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K042291

DateFirm and productCodeLinked 510(k)
May 28, 2020Beckman 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
JFLNone listed
Mar 30, 2019Beckman 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
JJENone listed
Jul 22, 2016Beckman 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
JJENone listed
Sep 23, 2014Beckman 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
JJENone listed
Jun 9, 2014Beckman 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
JJENone listed
Nov 19, 2012Beckman 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
CEMNone listed
Oct 24, 2012Beckman 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
JJENone listed
Oct 12, 2012Beckman 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
JJENone listed
Aug 23, 2012Beckman 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
JJENone listed
Aug 23, 2012Beckman 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
JJENone listed
Aug 23, 2012Beckman 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
JJENone listed
Jun 28, 2011Beckman Coulter Inc.
Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software version 4.3
Terminated
JJENone listed
Jun 23, 2011Beckman 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
JJENone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 26, 2011Beckman 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
CEMNone listed
Apr 13, 2011Beckman 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
JJENone listed
Apr 11, 2011Beckman 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
JJENone listed
Apr 11, 2011Beckman 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
JJENone listed
Apr 11, 2011Beckman 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
JJENone listed
Mar 9, 2011Beckman 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
CEMNone listed
Sep 9, 2010Beckman 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
CGANone listed
Mar 4, 2010Beckman 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
JJENone listed
May 24, 2008Beckman Coulter Inc
UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc.
Terminated
JJENone listed
May 24, 2008Beckman Coulter Inc
UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc.
Terminated
JJENone listed
May 24, 2008Beckman Coulter Inc
UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc.
Terminated
JJENone listed
May 24, 2008Beckman Coulter Inc
UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc.
Terminated
JJENone listed
May 25, 2006Beckman Coulter Inc
Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331
Terminated
JJENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.