510(k) K990172 ยท GKZ Counter, Differential Cell
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
| Applicant | Coulter Corp., Miami FL, US |
| Decision | Substantially Equivalent, Apr 13, 1999 |
| Received | Jan 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990172
| 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.