ClearanceBrief
510(k) K023049 ยท JGS Electrode, Ion Specific, Sodium

SYNCHRON LX I 725 CLINICAL SYSTEM

ApplicantBeckman Coulter, Inc., Brea CA, US
DecisionSubstantially Equivalent, Oct 4, 2002
ReceivedSep 12, 2002
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K023049

DateFirm and productCodeLinked 510(k)
Apr 1, 2013Beckman Coulter Inc.
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination
Terminated		 JJENone listed
Dec 22, 2012Beckman Coulter Inc.
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186
Terminated		 JJENone listed
Apr 6, 2012Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoa
Terminated		 JJENone listed
May 6, 2011Beckman Coulter Inc.
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Terminated		 JJENone listed
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		 JGSNone listed
Apr 12, 2011Beckman Coulter Inc.
SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration
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 20, 2010Beckman Coulter Inc.
Unicel Synchron Clinical Systems Closed Tube Aliquotter (CTA) for Synchron LXi 725, Part Number: 388982, Domestic; 389695, International The UniCel Synchron Clinical Systems are fully automated, compu
Terminated		 JJENone 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
Sep 21, 2008Beckman Coulter Inc
SYNCHRON LXi 725 System
Terminated		 JGSNone listed
Aug 20, 2008Beckman Coulter Inc
Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.
Terminated		 JJENone listed
May 24, 2008Beckman Coulter Inc
Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc.
Terminated		 JJENone listed
May 25, 2006Beckman Coulter Inc
SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724
Terminated		 JJENone listed
Oct 6, 2005Beckman Coulter Inc
Synchron LX Systems Version 4.5 Operating Software
Terminated		 JJENone listed
Jul 20, 2004Beckman Coulter Inc
Synchron LX Clinical Systems, Operating Software, All versions.
Terminated		 EXENone listed
Jul 20, 2004Beckman Coulter Inc
Synchron LX Clinical Systems Software
Terminated		 None listed
Nov 6, 2003Beckman Coulter Inc
Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
Terminated		 JQPNone listed
Mar 29, 2003Beckman Coulter Inc
Access 2 immunoassay side of LXi 725
Terminated		 None listed

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