510(k) K112933 ยท JNL Immunochemical, Thyroglobulin Autoantibody
ACCESS THYROGLOBULIN ANITBODY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 27, 2011 |
| Received | Oct 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112933
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Beckman Coulter, Inc. Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168.
The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determ Open, Classified |
JNL | None listed |
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 6 Terminated |
JNL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.