K221890
- 510(k) number
- K221890
- Device name
- Elecsys Tg II
- Applicant
- Roche Diagnostics IN · US
- Product code
- MSW — System, Test, Thyroglobulin
- Decision date
- 2023-09-30
- Date received
- 2022-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K221890.pdf
Official FDA record: K221890
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.