K213517
- 510(k) number
- K213517
- Device name
- Access Thyroglobulin Antibody II
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- JZO — System, Test, Thyroid Autoantibody
- Decision date
- 2023-09-26
- Date received
- 2021-11-03
- 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: K213517.pdf
Official FDA record: K213517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.