K223921
- 510(k) number
- K223921
- Device name
- Access CEA
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- DHX — System, Test, Carcinoembryonic Antigen
- Decision date
- 2023-09-22
- Date received
- 2022-12-29
- 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: K223921.pdf
Official FDA record: K223921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.