K232600
- 510(k) number
- K232600
- Device name
- DxFLEX Flow Cytometer; ClearLLab 10C Panels
- Applicant
- Beckman Coulter, Inc. FL · US
- Product code
- OYE — Flow Cytometric Reagents And Accessories.
- Decision date
- 2023-11-22
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K232600.pdf
Official FDA record: K232600
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.