510(k) K965240 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Dec 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2013 | Beckman Coulter Inc. ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915.
Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Terminated |
CEM | None listed |
| May 6, 2011 | Beckman Coulter Inc. Synchron LX20, Part Number: 466200.
Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Terminated |
JJE | None listed |
| Apr 26, 2011 | Beckman Coulter Inc. Synchron LX 20 PRO
The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic 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 |
| Sep 9, 2010 | Beckman Coulter Inc. SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525
Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma Terminated |
CGX | None listed |
| May 24, 2008 | Beckman Coulter Inc Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc. Terminated |
JJE | None listed |
| Oct 6, 2005 | Beckman Coulter Inc Synchron LX Systems Version 4.5
Operating Software Terminated |
JJE | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron LX Clinical Systems, Operating Software, All versions. Terminated |
EXE | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron LX Clinical Systems Software Terminated |
None listed | |
| Nov 6, 2003 | Beckman Coulter Inc Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems. Terminated |
JQP | None listed |
| Feb 5, 2003 | Beckman Coulter Inc SYNCHRON LX20 AND LX20 Pro Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.