K240996
- 510(k) number
- K240996
- Device name
- Access Thyroglobulin Antibody II
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- JNL — Immunochemical, Thyroglobulin Autoantibody
- Decision date
- 2024-07-03
- Date received
- 2024-04-11
- 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: K240996.pdf
Official FDA record: K240996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.