510(k) K031269 ยท MSW System, Test, Thyroglobulin
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Apr 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Beckman Coulter, Inc. Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 Open, Classified |
MSW | None listed |
| Oct 11, 2023 | Beckman Coulter, Inc. Access Thyroglobulin Calibrators Open, Classified |
MSW | None listed |
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniCel DxI Terminated |
MSW | None listed |
| May 9, 2017 | Beckman Coulter Inc. Access Thyroglobulin, A34085G, Catalog No. 33860 Terminated |
MSW | None listed |
| Sep 3, 2015 | Beckman Coulter Inc. Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. Terminated |
MSW | None listed |
| May 19, 2011 | Beckman Coulter Inc. Access Immunoassay Systems Thyroglobulin,
Part Number: 33860
This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid glan Terminated |
MSW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.