K240252
- 510(k) number
- K240252
- Device name
- 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. FL · US
- Product code
- GKZ — Counter, Differential Cell
- Decision date
- 2024-07-05
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K240252.pdf
Official FDA record: K240252
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.