510(k) K071681 ยท GKZ Counter, Differential Cell
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Oct 4, 2007 |
| Received | Jun 19, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071681
| 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 |
| Apr 30, 2008 | Beckman Coulter Inc Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.