K220972
- 510(k) number
- K220972
- Device name
- Access Thyroglobulin
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- MSW — System, Test, Thyroglobulin
- Decision date
- 2023-09-15
- Date received
- 2022-04-04
- 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: K220972.pdf
Official FDA record: K220972
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.