510(k) K213517 ยท JZO System, Test, Thyroid Autoantibody
Access Thyroglobulin Antibody II
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 26, 2023 |
| Received | Nov 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213517
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.