K240182
- 510(k) number
- K240182
- Device name
- Access EPO
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- GGT — Assay, Erythropoietin
- Decision date
- 2024-04-22
- Date received
- 2024-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K240182.pdf
Official FDA record: K240182
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.