510(k) K023764 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 28, 2003 |
| Received | Nov 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2025 | Beckman Coulter, Inc. UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Open, Classified |
JJE | None listed |
| Aug 5, 2025 | Beckman Coulter, Inc. DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 Open, Classified |
JJE | None listed |
| Aug 5, 2025 | Beckman Coulter, Inc. DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 Open, Classified |
JJE | None listed |
| Aug 5, 2025 | Beckman Coulter, Inc. UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 Open, Classified |
JJE | None listed |
| Aug 5, 2025 | Beckman Coulter, Inc. DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 Open, Classified |
JJE | None listed |
| Aug 5, 2025 | Beckman Coulter, Inc. DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 Open, Classified |
JJE | None listed |
| Jul 26, 2023 | Beckman Coulter, Inc. Ringed DxI Reaction Vessels (RVs) Open, Classified |
JJE | None listed |
| Mar 30, 2019 | Beckman Coulter Inc. The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line.
UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060.
Unicel DxI 800 Catalog Numbers: 9731 Open, Classified |
JJE | None listed |
| Sep 18, 2018 | Beckman Coulter Inc. The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immuno Terminated |
CGR | 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 |
| Feb 16, 2014 | Beckman Coulter Inc. UniCel DxI 600 Access Immunoassay System Analyzer.
The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various Terminated |
JJE | None listed |
| Nov 19, 2012 | Beckman Coulter Inc. UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457.
The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or Terminated |
JJE | None listed |
| Nov 19, 2012 | Beckman Coulter Inc. UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461.
The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or 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 |
| Jan 30, 2012 | Beckman Coulter Inc. UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100
UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260
UniCel DxC 600i, SYNCHRON Access Clinical Systems Part Numbers: A25656
Uni Terminated |
JJE | None listed |
| Jun 28, 2011 | Beckman Coulter Inc. Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3 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 |
| Dec 13, 2010 | Beckman Coulter Inc. Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N;
Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Ac Terminated |
JJE | None listed |
| Mar 2, 2010 | Beckman Coulter Inc. Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
Intended to be used with Terminated |
JJE | None listed |
| Feb 25, 2010 | Beckman Coulter Inc. UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1.
In vitro diagnostic device us Terminated |
JJE | None listed |
| Sep 21, 2008 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System Terminated |
JJE | None listed |
| Aug 20, 2008 | Beckman Coulter Inc Beckman Coulter UniCel Dxl 800 Access Immunoassay System;
Part Number: 973100
With: UniCel Dxl 800 Modification (MOD ID 10027)
and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnosti Terminated |
JJE | None listed |
| Mar 19, 2008 | Beckman Coulter Inc UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822 Terminated |
MMI | None listed |
| Sep 23, 2006 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer Terminated |
JJE | None listed |
| Mar 3, 2006 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier Terminated |
JJE | None listed |
| Dec 28, 2004 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Terminated |
JJE | None listed |
| Jul 20, 2004 | Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System, P/N 973100. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.