K241423
- 510(k) number
- K241423
- Device name
- Access Thyroglobulin
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- MSW — System, Test, Thyroglobulin
- Decision date
- 2024-06-07
- Date received
- 2024-05-20
- 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: K241423.pdf
Official FDA record: K241423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.