510(k) K232600 ยท OYE Flow Cytometric Reagents And Accessories.
DxFLEX Flow Cytometer; ClearLLab 10C Panels
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 22, 2023 |
| Received | Aug 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Beckman Coulter Inc. DxFLEX Flow Cytometer Catalog Number C78500
UDI-DI code: 15099590754013
The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent dete Open, Classified |
OYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.