510(k) K040026 ยท GKZ Counter, Differential Cell
BD FACS 7-COLOR SETUP BEADS
| Applicant | Becton Dickinson Immunocytometry Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | Jan 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2025 | Becton, Dickinson and Company, BD Bio Sciences REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation. Open, Classified |
GKZ | None listed |
| Jul 3, 2025 | Becton, Dickinson and Company, BD Bio Sciences REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation. Open, Classified |
GKZ | None listed |
| Sep 17, 2012 | BD Biosciences, Systems & Reagents BD FACS 7-color Setup beads
BD Biosciences, San Jose, CA 95131.
BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACS Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.