510(k) K193124 ยท GKZ Counter, Differential Cell
Unicel DxH 800 Coulter Cellular Analysis System
| Applicant | Beckman Coulter, Miami FL, US |
| Decision | Substantially Equivalent, Apr 16, 2020 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REFs:B24802, 629029, B63322 Open, Classified |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.