510(k) K140911 ยท GKZ Counter, Differential Cell
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Sep 5, 2014 |
| Received | Apr 9, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140911
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2019 | Beckman Coulter, Inc. UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide prepara Terminated |
GKZ | None listed |
| May 23, 2019 | Beckman Coulter Inc. UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322.
Product Usage:
The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automate Terminated |
GKZ | None listed |
| May 23, 2019 | Beckman Coulter Inc. UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858.
Product Usage:
Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop Terminated |
GKZ | None listed |
| May 23, 2019 | Beckman Coulter Inc. UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478
Product Usage:
Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a memb Terminated |
GKZ | None listed |
| Nov 3, 2017 | Beckman Coulter Inc. UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer Terminated |
GKZ | None listed |
| Nov 3, 2017 | Beckman Coulter Inc. UniCel DxH600, Part Number B23858, automated hematology analyzer
(Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, Terminated |
GKZ | None listed |
| Nov 3, 2017 | Beckman Coulter Inc. UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer Terminated |
GKZ | None listed |
| Jun 20, 2017 | Beckman Coulter Inc. UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2.
The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to use Terminated |
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 |
| Sep 2, 2016 | Beckman Coulter Inc. UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System.
Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System).
Catalog No. B23858 (Unicel DxH600 Coulter Ce Terminated |
GKZ | None listed |
| Aug 4, 2016 | Beckman Coulter Inc. UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222
UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer Terminated |
BSZ | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.