510(k) K040725 ยท GKZ Counter, Differential Cell
BD FACSCANTO SYSTEM
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | Mar 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040725
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2015 | BD Biosciences, Systems & Reagents BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway Terminated |
GKZ | None listed |
| Aug 8, 2008 | BD Biosciences BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System
Model/Catalog number 642685
Software is used to simplify acquisition of flow cytometry data. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.