510(k) K963263 ยท GKZ Counter, Differential Cell
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
| Applicant | Coulter Corp., Miami FL, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Aug 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2018 | Beckman Coulter Inc. COULTER EPICS XL Flow Cytometer
COULTER EPICS XL-MCL Flow Cytometer
SYSTEM II Software Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.