510(k) K030828 ยท GKZ Counter, Differential Cell
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, May 21, 2003 |
| Received | Mar 14, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K030828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2018 | Beckman Coulter Inc. 1) Cytomics FC 500 With CXP Software BECKMAN COULTER
2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER
flow cytometer for in vitro diagnostics Terminated |
GKZ | None listed |
| Oct 10, 2012 | Beckman Coulter Inc. TetraCXP Software System, Part Number A40051.
Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3 Terminated |
GKZ | None listed |
| Jan 13, 2009 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties o Terminated |
GKZ | None listed |
| Jan 7, 2009 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 Terminated |
GKZ | None listed |
| Aug 8, 2008 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628
A system for the qualitative and quantitative measurement of biological and physical pr Terminated |
GKZ | None listed |
| Apr 30, 2008 | Beckman Coulter Inc Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834 Terminated |
GKZ | None listed |
| Feb 8, 2007 | Beckman Coulter Inc Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version Terminated |
GKZ | None listed |
| Feb 8, 2007 | Beckman Coulter Inc Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 S Terminated |
GKZ | None listed |
| Feb 8, 2007 | Beckman Coulter Inc CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Softwar Terminated |
GKZ | None listed |
| Nov 21, 2006 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.