510(k) K240252 ยท GKZ Counter, Differential Cell
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 5, 2024 |
| Received | Jan 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C11478 Open, Classified |
GKZ | None listed |
| Sep 17, 2025 | Beckman Coulter Inc. UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C34520 Open, Classified |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.