510(k) K081930 ยท GKZ Counter, Differential Cell
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Jul 7, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2017 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322. Terminated |
GKZ | None listed |
| Apr 24, 2017 | Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. Terminated |
GKZ | None listed |
| Jan 11, 2017 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304 Terminated |
GKZ | None listed |
| Jan 11, 2017 | Beckman Coulter Inc. DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 Terminated |
GKZ | None listed |
| Dec 16, 2015 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802
The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology Terminated |
GKZ | None listed |
| Dec 16, 2015 | Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222
The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in Terminated |
GKZ | None listed |
| Dec 16, 2015 | Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole- Terminated |
GKZ | None listed |
| May 15, 2015 | Beckman Coulter Inc. COULTER DxH Diluent, Catalog No. 628017, Part No. A59956.
For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells. Terminated |
GIF | None listed |
| Jun 20, 2014 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465,
and B24802.
Used for in vitro diagnostic use in screening patient populations found in clinical laboratories. Terminated |
GKZ | None listed |
| Jun 20, 2014 | Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858.
Used for in vitro diagnostic use in screening patient populations found in clinical laboratories. Terminated |
GKZ | None listed |
| Nov 4, 2013 | Beckman Coulter Inc. UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems
The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in scree Terminated |
GKZ | None listed |
| Oct 9, 2012 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029.
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | None listed |
| Sep 1, 2011 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System
Product Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD The UniCel DxH 800 Analyzer is a quantitative, automate Terminated |
GKZ | None listed |
| May 20, 2011 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System.
A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Terminated |
GKZ | None listed |
| May 10, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System,
Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | None listed |
| May 9, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | None listed |
| May 5, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029.
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient pop Terminated |
GKZ | None listed |
| May 5, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popul Terminated |
GKZ | None listed |
| May 2, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popul Terminated |
GKZ | None listed |
| Apr 29, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | None listed |
| Apr 29, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popul Terminated |
GKZ | None listed |
| Apr 14, 2011 | Beckman Coulter Inc. UniCel DxH 800 Floor Cabinet Part Number: 723335
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clin Terminated |
GKZ | None listed |
| Apr 13, 2011 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popul Terminated |
GKZ | None listed |
| Apr 13, 2011 | Beckman Coulter Inc. UniCel DxH 800 Floor Cabinet Part Number: 723335
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in cli Terminated |
GKZ | None listed |
| Sep 1, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis
System Terminated |
GKZ | None listed |
| Jun 25, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System,
Part number(s): 629029 Terminated |
GKZ | None listed |
| May 26, 2010 | Beckman Coulter Inc. Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in Terminated |
GKZ | None listed |
| May 26, 2010 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient popu Terminated |
GKZ | None listed |
| May 26, 2010 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient pop Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.