K234052
- 510(k) number
- K234052
- Device name
- Access Ferritin
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Decision date
- 2024-03-20
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K234052.pdf
Official FDA record: K234052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.