510(k) K120771 ยท GKZ Counter, Differential Cell
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Mar 22, 2013 |
| Received | Mar 14, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K120771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF:B23858 Open, Classified |
GKZ | None listed |
| 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.