K240403
- 510(k) number
- K240403
- Device name
- Access BR Monitor
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- MOI — System, Test, Immunological, Antigen, Tumor
- Decision date
- 2024-05-09
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240403.pdf
Official FDA record: K240403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.